6100

• FDA PMA P010012 decided 2 May 2002 Active
• FDA GUDID UDI-DI 00802526463556 listed 24 Sep 2014 Listed

• • Ongoing Z-1671-2022 FDA Class II ·initiated 7 Jul 2022 ·on shared PMA P010012

  There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

• 3 recalls, same reason

  • Terminated Z-0080-2018 FDA Class II ·initiated 4 Oct 2017 ·on shared PMA P010012
  • Terminated Z-0079-2018 FDA Class II ·initiated 4 Oct 2017 ·on shared PMA P010012
  • Terminated Z-0081-2018 FDA Class II ·initiated 4 Oct 2017 ·on shared PMA P010012

  The devices have an incorrect firmware configuration.

• • Terminated Z-1556-2010 FDA Unclassified (pre-2012) ·initiated 15 Mar 2010

  Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration.

• • Terminated Z-0609-2010 FDA Unclassified (pre-2012) ·initiated 1 Dec 2009

  BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise

• 6 recalls, same reason

  • Terminated Z-1055-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012
  • Terminated Z-1049-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012
  • Terminated Z-1052-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012
  • Terminated Z-1047-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012
  • Terminated Z-1053-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012
  • Terminated Z-1054-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared PMA P010012

  Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.

• • Terminated Z-0047-2008 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007

  Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Upd

• • Terminated Z-1288-06 FDA Unclassified (pre-2012) ·initiated 15 May 2006 ·on shared PMA P010012

  Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.

• 3 recalls, same reason

  • Terminated Z-0825-06 FDA Unclassified (pre-2012) ·initiated 7 Apr 2006 ·on shared PMA P010012
  • Terminated Z-0826-06 FDA Unclassified (pre-2012) ·initiated 7 Apr 2006 ·on shared PMA P010012
  • Terminated Z-0827-06 FDA Unclassified (pre-2012) ·initiated 7 Apr 2006 ·on shared PMA P010012

  77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.

• • Terminated Z-0863-06 FDA Unclassified (pre-2012) ·initiated 11 Mar 2006 ·on shared PMA P010012

  Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.

• • Terminated Z-0891-06 FDA Unclassified (pre-2012) ·initiated 30 Sep 2005 ·on shared PMA P010012

  Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.

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

1. 23 Mar 2007 Recall initiated FDA recalls Z-1047-2007
2. 23 Mar 2007 Recall initiated FDA recalls Z-1053-2007
3. 23 Mar 2007 Recall initiated FDA recalls Z-1054-2007
4. 1 Dec 2009 Recall initiated FDA recalls Z-0609-2010
5. 15 Mar 2010 Recall initiated FDA recalls Z-1556-2010
6. 24 Sep 2014 Listed FDA GUDID 00802526463556
7. 4 Oct 2017 Recall initiated FDA recalls Z-0080-2018
8. 4 Oct 2017 Recall initiated FDA recalls Z-0079-2018
9. 4 Oct 2017 Recall initiated FDA recalls Z-0081-2018
10. 7 Jul 2022 Recall initiated FDA recalls Z-1671-2022

11 earlier events are in the sections above.

Generic name

Implantable electrical stimulation lead suture sleeve

Model / reference

6100

Primary DI / UDI-DI

00802526463556

PMA number

P010012 ↗

FDA product code

LWP

GMDN term

Implantable electrical stimulation lead suture sleeve

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: Implantable electrical stimulation lead suture sleeve

Other devices filed under FDA product code LWP (Implantable pulse generator, pacemaker (non-CRT)).

• 2292 by MEDTRONIC, INC.
• Aurora Models 6291 and 6292 Pacemakers by ST. JUDE MEDICAL, INC.
• Percepta Bipolar CRT-P by MEDTRONIC, INC.
• Paragon/Phoenix Family of Pacemakers by ST. JUDE MEDICAL, INC.
• DDD Pulse Generator 674 by Pacesetter Systems
• PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P by Pacesetter Systems
• Chorus DDD Pacemaker by MicroPort CRM USA, Inc.
• Gemini Theta Model 415A Cardiac Pacer by Telectronics Pacing Systems, Inc.
• Versatrax Model 7000 Universal A-V Pulse Generator by Medtronic Cardiac Rhythm Disease Management
• Tendril MRI Lead (Model LPA 1200M) by Abbott Medical

• OPAL HDx™ M004OPAL14010

  Class II

  GUDID on market

• Acuity™

  Class III

  CE/MDD

• WALLSTENT-Uni™

  Class IIb

  CE/MDD

• Multi-Point Thermal Sensor

  Class IIa

  CE/MDR

See all devices from Boston Scientific →