FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 4173865
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16656
- Event Type
- Malfunction
- Date Received
- October 15, 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
- TX, 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 THE PATIENT PRESENTED WITH AN EPISODE OF VENTRICULAR FIBRILLATION WHICH WAS INTERMITTENTLY UNDERSENSED, CAUSING THE DEVICE TO INAPPROPRIATELY RETURN TO SINUS. THE PATIENTS RHYTHM SPONTANEOUSLY CONVERTED. PROGRAMMING CHANGES WERE RECOMMENDED. NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655658 | 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 |