Recall Z-0022-2016
Medtronic Inc. Cardiac Rhythm Disease Management · initiated September 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: no codes on the cards
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.
FDA-determined 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.
Details
- Recall number
- Z-0022-2016
- Initiated
- September 15, 2015
- Posted by FDA
- October 5, 2015
- Terminated
- April 14, 2016
- Product code
- DTB – Permanent Pacemaker Electrode
- Quantity
- 777 cards
- Distribution
- US nationwide distribution.
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN