FDA Adverse Event
Injury
Summary report: N
ATLAS II PLUS DR
MDR report key: 3090073
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01288
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- February 4, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USAGE DATA AND THE DEVICE WAS FOUND TO MEET ITS LONGEVITY REQUIREMENT. THE DEVICE WAS ANALYZED ON THE BENCH AND ALL SPECIFICATIONS WERE MET. NO ANOMALIES WERE DETECTED THE DEVICE WAS FOUND TO BE NORMAL IN THE LABORATORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE ERI AND INAPPROPRIATE SHOCKS. THE PATIENT IS A TWIDDLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191929 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |