FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D
MDR report key: 3890849
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03712
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- August 15, 2011
- Manufacturer
- ST. JUDE MEDICAL INC. CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY THE MFR, NO MEDWATCH FORM WAS RECEIVED. 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 THE DEVICE WAS POST PACED T WAVE OVERSENSING. THE COMPLAINT WAS RESOLVED NON INVASIVELY BY REPROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30367 | PROMOTE PLUS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK | NIK | ST. JUDE MEDICAL INC. CRMD | CD3211-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |