FDA Adverse Event
Malfunction
Summary report: N
AFFINITY DR
MDR report key: 4190090
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02266
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- April 12, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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 PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. IT WAS CLINICALLY RESOLVED BY A SUCCESSFUL SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21581 | AFFINITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC. CRMD | 5330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |