FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS VR
MDR report key: 2242446
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06626
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- July 6, 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
BASED ON DEVICE SETTINGS, THE DEVICE WAS BELOW THE OVERALL EXPECTED LONGEVITY. NO HIGH CURRENT DRAIN SOURCES WERE FOUND THROUGHOUT BENCH AND AUTOMATED TESTING. THE BATTERY WAS SENT TO THE VENDOR. NO ANOMALIES WERE FOUND THAT WOULD CAUSE PREMATURE DEPLETION. 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT NO COMMUNICATION COULD BE ESTABLISHED. DEVICE WAS EXPLANTED.
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 | 55 YR | Required Intervention |