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 patient by Medtronic after device registration.
This recall has been terminated (originally issued October 5, 2015).
- Recall Initiated
- September 15, 2015
- Posted
- October 5, 2015
- Terminated
- April 14, 2016
- Recall Number
- Z-0022-2016
- Quantity
- 777 cards
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US nationwide distribution.
Lot / Code Info
no codes on the cards
Root Cause
Process control
Action Taken
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.