FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D
MDR report key: 4220980
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17484
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 18, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK-UP VVI MODE. A DEVICE DOWNLOAD WAS SUCCESSFULLY PERFORMED AND THE NON-PACEMAKER PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702701 | PROMOTE PLUS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |