FDA Adverse Event
Injury
Summary report: N
PROMOTE RF CRT-D
MDR report key: 3210559
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03291
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 21, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW UP, UPON INTERROGATION THEY RECEIVED AN ALERT FOR DEVICE HAD REACHED ERI AND THAT THE PATIENT NOTIFIER HAD BEEN DELIVERED FOR ERI AND SOFTWARE RESET. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309042 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |