FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 2243085
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06620
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 29, 2011
- 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
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED VIA REVIEW OF BATTERY MEASUREMENT DATA. THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE DETECTED. THE BATTERY WAS RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WITHIN THE BATTERY WAS FOUND TO BE THE CAUSE OF 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 THE DEVICE COULD NOT BE INTERROGATED. PREMATURE ERI SUSPECTED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |