FDA Adverse Event
Malfunction
Summary report: N
ACCENT SR RF OUS
MDR report key: 4143335
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05769
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 9, 2012
- Manufacturer
- ST. JUDE MEDICAL INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP. THE PULSE GENERATOR EXHIBITED FALSE PREMATURE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27730 | ACCENT SR RF OUS | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL INC. CRMD | PM1210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |