{
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  "cite_as": "Bionic Navigator™ SC-7101-102, Boston Scientific Neuromodulation. deviCERTS medical device catalogue. https://devicerts.com/devices/bionic-navigator-sc-7101-102 (data as of 2026-11-14).",
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    "markdown_url": "https://devicerts.com/devices/bionic-navigator-sc-7101-102.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
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    "registry_records_last_synced": "2026-10-23",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/bionic-navigator-sc-7101-102",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
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    "name": "Bionic Navigator™ SC-7101-102",
    "registry_name": "Bionic Navigator™ SC-7101-102",
    "url": "https://devicerts.com/devices/bionic-navigator-sc-7101-102",
    "manufacturer": {
      "name": "Boston Scientific Neuromodulation",
      "url": "https://devicerts.com/manufacturers/boston-scientific-neuromodulation",
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      "label": "Active",
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      {
        "class": "Class III",
        "system": "US FDA"
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          {
            "value": "08714729935087",
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        "label": "PMA number",
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          {
            "value": "P030017",
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    "product_codes": [
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      {
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        "term": "Implantable electrical stimulation device management software"
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      "type": "GUDID listing",
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      "device_udi_di": null,
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      "reason": "Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.",
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      "reason": "Sterile anchors my lack sterility assurance.",
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      "reason": "Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.",
      "applies": "this device",
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    },
    {
      "number": "Z-2124-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the \"use by date\" displayed on the label which is later than the correct \"use by date\". No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-2122-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the  \"use by date\" displayed on the label which is later than the correct \"use by date\". No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-2119-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the  \"use by date\" displayed on the label which is later than the correct \"use by date\". No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-2123-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to \"use by date\" displayed on the label which is later than the correct \"use by date\". No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-2121-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the \"use by date\" displayed on the label which is later than the correct \"use by date\".  No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-2120-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-24",
      "reason": "The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the  \"use by date\" displayed on the label which is later than the correct \"use by date\". No adverse health consequence is expected to occur from this issue.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-1409-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-03-19",
      "reason": "Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.",
      "applies": "this device",
      "via": "P030017"
    },
    {
      "number": "Z-0271-2009",
      "classification": "",
      "status": "terminated",
      "initiated": "2008-09-22",
      "reason": "Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-1441-2012",
      "classification": "",
      "status": "terminated",
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      "reason": "The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.",
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      "via": "P030017"
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    {
      "number": "Z-0960-2008",
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      "status": "terminated",
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      "reason": "Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of \"10h0\" or \"00h0\" through the Remote Control.  Under this condition, the IPG will cease to log in some data that could be used for informational purposes.  ** It should be noted t",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-0055-2008",
      "classification": "",
      "status": "terminated",
      "initiated": "2007-08-03",
      "reason": "Mislabeled: Product labeled with the incorrect shelf-life information.",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-0700-2007",
      "classification": "",
      "status": "terminated",
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      "reason": "The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-0299-2007",
      "classification": "",
      "status": "terminated",
      "initiated": "2006-09-21",
      "reason": "A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material.  At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.",
      "applies": "this device",
      "via": "P030017"
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    {
      "number": "Z-0396-05",
      "classification": "",
      "status": "terminated",
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      "reason": "A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.",
      "applies": "this device",
      "via": "P030017"
    }
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