FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR
MDR report key: 3920795
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14401
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 WAS PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE ALSO INDICATED IT REACHED END OF SERVICE. AFTER A FIRMWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398393 | ACCENT DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |