FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D
MDR report key: 1954808
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00528
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 16, 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
- TN
- 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 OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE FOUND DAMAGE TO THE OUTPUT CIRCUITRY CONSISTENT WITH DELIVERY OF HIGH VOLTAGE THERAPY INTO A LOW IMPEDANCE LOAD. IT IS BELIEVED THAT THE ROOT CAUSE IS A SHORT IN THE HV LEAD. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND ON THE AUTOMATED TEST SYSTEM. ALL LOW VOLTAGE DEVICE FUNCTIONS WERE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT RAPIDLY. AT IMPLANT, THE DEVICE EXPERIENCED A RESET DUE TO A SUSPECTED DAMAGED LEAD. THE DEVICE WAS RESTORED AT THAT TIME. THE DEVICE AND LEAD WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | 1580/65, (B)(4) |