FDA Adverse Event
Injury
Summary report: N
EPIC HF CRT-D
MDR report key: 1831005
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03671
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 2, 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
- WI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS COULD NOT CONFIRM THE REPORTED PREMATURE BATTERY DEPLETION. BASED ON PROGRAMMED PARAMETERS AND DEVICE DIAGNOSTICS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION. THE DEVICE WAS TESTED ON OUR AUTOMATED TESTING EQUIPMENT AND NO DEVICE ANOMALY WAS DETECTED. THE DEVICE IS NORMAL.
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
IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-337 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |