FDA Adverse Event
Malfunction
Summary report: N
AFFINITY DR
MDR report key: 1896704
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05270
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 22, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MEASURED DATA WAS NOT CORRECTLY CALCULATING THE PULSE GENERATOR CURRENT DRAIN. THE BATTERY DATA WAS 2.56 V, LESS THAN 1 UA, 26.4 KOMS WITH LESS THAN ONE MONTH REMAINING UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS PROGRAMMED FROM DDD 2.5 V, 0.4 MS TO DDD 3.0 V, 0.4 MS ON BOTH CHANNELS.
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 | 5330R | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |