FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 3920788
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14381
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 THE PATIENT WAS PRESENTED VIA MERLIN.NET AND THE PULSE GENERATOR WAS FOUND IN BACKUP VVI MODE. THE PATIENT WAS BROUGHT INTO CLINIC FOR FURTHER TROUBLESHOOTING. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398307 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |