FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1954684
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00135
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 20, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. DURING ANALYSIS, DEVICE FUNCTION WAS NORMAL. THE DEVICE WAS PLACED IN A TEMPERATURE AND HUMIDITY TEST. THE DEVICE'S POWER CONSUMPTION WAS FOUND TO BE NORMAL. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL BATTERY ANOMALY WAS FOUND TO CAUSE THE PREMATURE BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |