FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D
MDR report key: 3101199
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01993
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- February 12, 2013
- 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 THE REPORTED FIELD EVENT OF HIGH CAPTURE THRESHOLD COULD NOT BE CONFIRMED IN THE LABORATORY. BASED ON PROGRAMMED SETTINGS AND USAGE DATA, A LONGEVITY CALCULATION WAS PERFORMED AND AND THE BATTERY WAS WITHIN THE NORMAL LONGEVITY ESTIMATIONS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE DETECTED.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO HIGH PACING THRESHOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203531 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |