FDA Adverse Event
Malfunction
Summary report: N
AFFINITY DR
MDR report key: 4142989
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05602
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- December 15, 2011
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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. INITIAL REPORTER: COMPANY REP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED OVERSENSING FAR R WAVES WITH AUTOMATIC MODE SWITCHES. IT WAS CLINICALLY RESOLVED BY REPROGRAMMING. DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31622 | AFFINITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, CRMD | 5330L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |