FDA Adverse Event
Injury
Summary report: N
AFFINITY DC
MDR report key: 2240384
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05876
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- June 30, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACKUP MODE DUE TO MULTIPLE FLIPPED BITS. THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND COULD NOT BE DOWNLOADED. A HIGH CURRENT DRAIN WAS OBSERVED. THIS WAS DUE TO A DISCREPANT INTEGRATED CIRCUIT.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP OPERATION. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY DC | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5230 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |