FDA Adverse Event
Injury
Summary report: N
ATLAS II HF CRT-D
MDR report key: 1895948
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04790
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 16, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. A LONGEVITY ESTIMATION WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION. HOWEVER, THE BATTERY VOLTAGE DROPPED FROM ERI TO EOL PREMATURELY. AN INTERNAL ANOMALY WAS FOUND WITHIN THE BATTERY THAT RESULTED IN THE PREMATURE DEPLETION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. WHEN THE DEVICE WAS DEACTIVATED FOR EXPLANT, THE PATIENT WENT ASYSTOLIC DUE TO OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS II HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |