FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 4173849
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16644
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT VIA REMOTE TRANSMISSION, CHRONIC ATRIAL FIBRILLATION WAS OBSERVED. UPON DEVICE INTERROGATION, IT WAS FOUND OUT THAT ATRIAL FIBRILLATION DIAGNOSTICS SHOWED ZERO PERCENT SINCE LAST FOLLOW-UP. PATIENT WILL CONTINUE TO BE MONITORED CLOSELY. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656189 | PROMOTE PLUS CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |