URGENT MEDICAL DEVICE RECALL

For a Subset of Medtronic
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and
Implantable Cardioverter Defibrillators (ICDs)

Device Model and Serial Numbers in Appendix A

January 2018,

Dear Physician or Healthcare Professional,

Medtronic is writing to inform you of a potential issue that may occur in an identified set of 48 Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs). These devices underwent a specific sequence of manufacturing processes that could result in an unexpected loss of device functionality, including high-voltage therapy. Refer to Appendix A for a complete list of model and serial numbers for this identified sub-population of devices. No other Medtronic devices are included in this advisory.

These 48 devices were sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality. Through 12 January 2018, Medtronic has confirmed one (1) implanted device failure resulting in loss of high-voltage therapy related to this issue, where the patient was rescued with external defibrillation.

Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure. Based on testing of a limited number of available devices that underwent this manufacturing sequence, this failure was observed during high-voltage cycle testing to battery depletion in 23% of these devices, with failure observed within the first two (2) high-voltage charges in 7.7% of the tested devices. Successful delivery of previous high-voltage therapy does not guarantee future performance.

Medtronic records indicate you are following one or more patients implanted with an affected device as noted in the enclosed Physician / Patient Detail Report.

Patient Management Recommendations

We realize that each patient requires unique clinical considerations. In consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic provides the following recommendation:

  • Prophylactic device replacement should be strongly considered for patients who have been implanted with one of the devices listed in Appendix A.              

Medtronic will offer a supplemental device warranty for this affected population. Contact your Medtronic sales representative for terms and conditions. Medtronic will notify all applicable regulatory agencies about this matter.  Please share this notification with others in your organization as appropriate.

We sincerely regret any difficulties this may cause you and your patients. Medtronic remains dedicated to patient safety and will continue to monitor device performance to ensure we meet your needs and those of your patients. Medtronic Patient Services is available to assist patients at 800-551-5544 (Monday-Friday, 8am-5pm Central Time). If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Sincerely,

Tim Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Heart Failure


Appendix A: Device Model and Serial Number Information

Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds)

Device Name

Device Model

Device Serial Number

Amplia MRI CRT-D DF4

DTMB1D4

RPJ201956H

Amplia MRI Quad CRT-D DF4

DTMB1QQ

RPE201417H

RPE204789H

RPE206207H

RPE207850H

RPE209095H

RPE212027H

Claria MRI Quad CRT-D DF4

DTMA1QQ

RPA204495H

Compia MRI Quad CRT-D DF4

DTMC1QQ

RPL201034H

Viva® Quad S CRT-D DF4

DTBB1QQ

BLK204122H

Viva® Quad XT CRT-D DF4

DTBA1QQ

BLC224272H

BLC227175H

BLC227641H

Viva® S CRT-D DF1

DTBB1D1

BLO204984H

Viva® XT CRT-D DF1

DTBA1D1

BLF216780H

BLF231229H

BLF250740H

BLF251155H

BLF255165H

Viva® XT CRT-D DF4

DTBA1D4

BLE220200H

Implantable Cardioverter-Defibrillators (ICDs)

Device Name

Device Model

Device Serial Number

Evera MRI® XT DR DF1

DDMB1D1

CWA200012H

CWA202259H

CWA203498H

Evera MRI® XT DR DF4

DDMB1D4

PFZ214605H

PFZ228504H

PFZ228590H

PFZ228836H

PFZ228838H

PFZ229236H

Evera MRI® XT VR DF4

DVMB1D4

PKZ203327H

PKZ210673H

Evera MRI S DR ICD DF1

DDMC3D1

CWC200055H

Evera® S DR ICD DF1

DDBC3D1

BWG204574H

Evera® S VR DF1

DVBC3D1

BWM204635H

Evera® XT DR DF1

DDBB1D1

BWC223253H

BWC233374H

BWC234767H

BWC234772H

Evera® XT VR DF1

DVBB1D1

BWI208876H

Evera® XT VR ICD DF4

DVBB1D4

BWH201158H

BWH214640H

Visia AF MRI VR SureScan DF1

DVFB1D1

CWG200402H

Visia AF MRI VR SureScan DF4

DVFB1D4

PKX202448H

PKX205417H

PKX205779H

PKX209277H

PKX212710H

Visia AF VR DF1

DVAB1D1

BWN201126H