FDA Adverse Event
Malfunction
Summary report: N
ACCENT SR RF OUS
MDR report key: 4192278
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04105
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- August 8, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. FINAL ANALYSIS FOUND THAT THE DEVICE EXHIBITED BACKUP VVI MODE DUE TO POWER ON RESET. AFTER A PRODUCT CODE DOWNLOAD, NORMAL FUNCTION RESUMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE PULSE GENERATOR EXHIBITED AN ERROR MESSAGE AND ERRATIC IMPEDANCE VALUES. THE DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27443 | ACCENT SR RF OUS | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC. CRMD | PM1210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |