FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D
MDR report key: 3880630
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03406
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- November 20, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP THE DEVICE EXHIBITED INTERMITTENT T-WAVE OVERSENSING. IT WAS RECOMMENDED THAT THE DEVICE BE REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25101 | PROMOTE PLUS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK | NIK | ST. JUDE MEDICAL INC., CRMD | CD3211-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |