FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 4181819
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02845
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 23, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED FAR FIELD R WAVE OVERSENSING WAS FOUND DURING F/U. REPROGRAMMING WAS RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25202 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D | CD3231-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |