FDA Adverse Event
Injury
Summary report: N
ACCENT DR
MDR report key: 1955598
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-01195
- Event Type
- Injury
- Date Received
- January 10, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED NO OUTPUT OR TELEMETRY. BATTERY DEPLETION ALSO OCCURRED DUE A HIGH CURRENT DRAIN WHICH WAS CAUSED BY A SHORTED CAPACITOR. AFTER REPLACING THE CAPACITOR, NORMAL FUNCTION ENSUED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR REACHED END OF SERVICE (EOS) ON (B)(6), 2010 AND REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6), 2010. THE DEVICE'S BATTERY VOLTAGE WAS LESS THAN 2.1 VOLTS AND CURRENT DRAIN WAS 11 UA. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCENT DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM2110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |