FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF
MDR report key: 4073636
·
Received September 9, 2014
Report
- Report Number
- 2017865-2014-16692
- Event Type
- Malfunction
- Date Received
- September 9, 2014
- Date of Event
- July 31, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0429
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT VIA A MERLIN.NET TRANSMISSION, THE ATRIAL LEAD EXHIBITED UNDERSENSING. THE DEVICE WOULD BE REPROGRAMMED AND THE PATIENT MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553943 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |