FDA Adverse Event
Injury
Summary report: N
ATLAS DR
MDR report key: 2243106
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06635
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 20, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT. NO HIGH CURRENT DRAIN SOURCES WERE FOUND. THE BATTERY WAS RETURNED TO THE MANUFACTURER FOR ADDITIONAL ANALYSIS. AN INTERNAL ANOMALY WAS FOUND TO BE THE CAUSE OF THE REPORTED PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT LAST FOLLOW-UP DEVICE COULD NOT BE INTERROGATED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-242 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |