FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 2408962
·
Received January 10, 2012
Report
- Report Number
- 2017865-2012-00658
- Event Type
- Injury
- Date Received
- January 10, 2012
- Date of Event
- October 24, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
RESET OF THE DEVICE WAS CONFIRMED. THE DEVICE ATTEMPTED TO INITIATE A CHARGE WHILE THE PATIENT WAS GOING THROUGH AN MRI PROCEDURE, EXPOSING THE DEVICE TO EMI AND RESULTING IN RESET.
Description of Event or Problem · 1
AN ASYMPTOMATIC PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP WITH THE DEVICE IN BACKUP VVI. IT WAS NOTED THAT THE DEVICE WAS EXPOSED TO MRI. POWER ON RESET OCCURRED, THE DATE OF THE MRI PROCEDURE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |