Recall Z-0022-2016 ยท DTB Permanent Pacemaker Electrode
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patie
| Date | Oct 5, 2015 (initiated Sep 15, 2015) |
| Status | Terminated |
| Reason | Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional. |
| Root cause | Process control |
| Action | On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time. |
| Quantity | 777 cards |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |