FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF4 CONNECTOR
MDR report key: 3210561
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03417
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 15, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP AFTER RECEIVING INAPPROPRIATE SHOCKS. ATRIAL UNDERSENSING WAS OBSERVED. THE PATIENT'S RHYTHM WAS ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. REPROGRAMMING THE DEVICE WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311519 | PROMOTE PLUS CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |