FDA Adverse Event
Injury
Summary report: N
EPIC II HF CRT-D
MDR report key: 1955252
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00592
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 1, 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
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED RESET ANOMALY WAS VERIFIED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. WITH A NEW BATTERY, THE DEVICE TESTED NORMAL. IT IS BELIEVED THAT THE EXTERNAL NOISE DUE TO A DAMAGED LEAD AND THE RESULTANT HIGH VOLTAGE THERAPY USAGE CONTRIBUTED TO THE RESET AND BATTERY DEPLETION.
Description of Event or Problem · 1
PATIENT RECEIVED MULTIPLE SHOCKS, WENT TO ER AND PRESENTED IN VT. UPON INTERROGATION, DEVICE WAS FOUND IN BACKUP HARDWARE RESET. THE RV LEAD HAS SHOWN LOW IMPEDANCE VALUES. BOTH LEAD AND ICD WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC II HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-355 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | (B)(4) |