FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR, DF-4 CONNECTOR
MDR report key: 3210441
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03372
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 2, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON THE AVAILABLE PARAMETER AND USAGE INFORMATION, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE ORIGINAL BATTTERY WAS RETURNED TO THE VENDER FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.
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 DEVICE BATTERY VOLTAGE DROPPED SIGNIFICANTLY OVER A PERIOD OF A FEW DAYS AND REACHED ERI. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309731 | CURRENT PLUS DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |