FDA Adverse Event
Malfunction
Summary report: N
AFFINITY DR
MDR report key: 293032
·
Received July 11, 2000
Report
- Report Number
- 2017865-2000-00963
- Event Type
- Malfunction
- Date Received
- July 11, 2000
- Date of Event
- May 22, 2000
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE FIELD NOTES THAT ALTHOUGH THE PATIENT FELT FINE POST IMPLANT, A FEW DAYS LATER, SHE HAD NONSPECIFIC COMPLAINTS. UPON INTERROGATION, A MESSAGE THAT THE LEAD TYPES HAD NOT BEEN PROGRAMMED WAS DISPLAYED. THE DEVICE WAS FOUND TO BE PROGRAMMED TO THE INITIAL SHIPPED SETTINGS. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS SENT HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5330L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |