Na 8529

• • Ongoing Z-2201-2026 FDA Class II ·initiated 8 Apr 2026 ·on shared PMA P860004

  Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

• • Ongoing Z-1506-2025 FDA Class II ·initiated 9 Jan 2025 ·on shared PMA P860004

  Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

• • Ongoing Z-2352-2024 FDA Class II ·initiated 10 May 2024 ·on shared PMA P860004

  Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

• 2 recalls, same reason

  • Ongoing Z-0615-2024 FDA Class II ·initiated 13 Nov 2023 ·on shared PMA P860004
  • Ongoing Z-0614-2024 FDA Class II ·initiated 13 Nov 2023 ·on shared PMA P860004

  Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

• • Ongoing Z-0896-2018 FDA Class II ·initiated 9 Aug 2017 ·on shared PMA P860004

  Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.

• • Completed Z-0522-2024 FDA Class II ·initiated 13 Jul 2020 ·on shared PMA P860004

  The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

• • Terminated Z-0508-2020 FDA Class I ·initiated 11 Oct 2019 ·on shared PMA P860004

  There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

• • Terminated Z-0537-2018 FDA Class III ·initiated 21 Sep 2017 ·on shared PMA P860004

  There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.

• • Terminated Z-0788-2017 FDA Class I ·initiated 3 Oct 2016 ·on shared PMA P860004

  Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.

• • Terminated Z-1271-2016 FDA Class II ·initiated 9 Feb 2016 ·on shared PMA P860004

  Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.

• • Terminated Z-1681-2015 FDA Class II ·initiated 10 Apr 2015 ·on shared PMA P860004

  Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.

• 3 recalls, same reason

  • Terminated Z-1061-2011 FDA Unclassified (pre-2012) ·initiated 14 Jan 2011 ·on shared PMA P860004
  • Terminated Z-1062-2011 FDA Unclassified (pre-2012) ·initiated 14 Jan 2011 ·on shared PMA P860004
  • Terminated Z-1060-2011 FDA Unclassified (pre-2012) ·initiated 14 Jan 2011 ·on shared PMA P860004

  This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum

• • Terminated Z-2276-2009 FDA Unclassified (pre-2012) ·initiated 1 Jul 2009 ·on shared PMA P860004

  This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence

• • Terminated Z-1214-2010 FDA Unclassified (pre-2012) ·initiated 23 Mar 2009 ·on shared PMA P860004

  Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump programming errors that result in overdos

• 4 recalls, same reason

  • Terminated Z-2172-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008 ·on shared PMA P860004
  • Terminated Z-2174-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008 ·on shared PMA P860004
  • Terminated Z-2171-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008 ·on shared PMA P860004
  • Terminated Z-2173-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008 ·on shared PMA P860004

  The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.

• 13 recalls, same reason

  • Terminated Z-1147-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1144-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1154-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1149-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1143-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1151-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1153-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1150-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1148-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1152-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1145-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1142-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004
  • Terminated Z-1146-2008 FDA Unclassified (pre-2012) ·initiated 16 Jan 2008 ·on shared PMA P860004

  Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d

• • Terminated Z-0739-2008 FDA Unclassified (pre-2012) ·initiated 3 Aug 2007 ·on shared PMA P860004

  Pump motor stall due to gear shaft wear

• 2 recalls, same reason

  • Terminated Z-1415-06 FDA Unclassified (pre-2012) ·initiated 21 Jul 2006 ·on shared PMA P860004
  • Terminated Z-1414-06 FDA Unclassified (pre-2012) ·initiated 21 Jul 2006 ·on shared PMA P860004

  Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.

• • Terminated Z-0391-05 FDA Unclassified (pre-2012) ·initiated 19 Nov 2004 ·on shared PMA P860004

  Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).

• • Terminated Z-1334-04 FDA Unclassified (pre-2012) ·initiated 24 Aug 2004 ·on shared PMA P860004

  With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

• • Terminated Z-1384-04 FDA Unclassified (pre-2012) ·initiated 23 Jul 2004 ·on shared PMA P860004

  The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Active implantable device control magnet

Model / Reference

8529

Primary DI / UDI-DI

00613994997937

PMA Number

P860004 ↗

FDA Product Code

KMN, PJS

GMDN Term

Active implantable device control magnet

Device Class

Class I

Regulation Number

880.6140

GUDID distribution status

In Commercial Distribution

Category: Active implantable device control magnet

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