FDA Adverse Event
Injury
Summary report: N
ATLAS PLUS HF CRT-D
MDR report key: 1895868
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04781
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 27, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. BASED ON DEVICE PROGRAMMED SETTINGS AND USAGE INFORMATION, A LONGEVITY CALCULATION WAS PERFORMED. THE BATTERY WAS FOUND TO BE WITHIN NORMAL LONGEVITY ESTIMATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY WAS DEPLETING TOO QUICKLY. THE PATIENT HAD NOT HAD ANY THERAPIES OR ABORTED SHOCKS SINCE THE PREVIOUS FOLLOWUP IN (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |