FDA Adverse Event
Malfunction
Summary report: N
PROMOTE RF CRT-D
MDR report key: 3920907
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13338
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- December 9, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED A MERLIN.NET TRANSMISSION DISPLAYED A MODE SWITCH EPISODE WITH NO APPARENT INCREASE IN ATRIAL EVENTS TO EXPLAIN A DECREASE IN THE FILTERED ATRIAL RATE INTERVAL (FARI). RECOMMENDED PROGRAMMING CHANGES WERE MADE. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398463 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | 3213-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |