FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 3210554
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03532
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 24, 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
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE DEVICE WAS TESTED ON THE BENCH AND CURRENT DRAIN WAS NORMAL IN THE LABORATORY. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WITHIN THE BATTERY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT RAPID BATTERY DEPLETION WAS OBSERVED ON AN ASYMPTOMATIC PATIENT. THE BATTERY WENT FROM NORMAL TO END OF SERVICE WITHIN 3 MONTHS. THE DEVICE WAS REPLACED AND RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310204 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |