FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D, DF4 CONNECTOR
MDR report key: 3794656
·
Received May 6, 2014
Report
- Report Number
- 2938836-2014-10620
- Event Type
- Malfunction
- Date Received
- May 6, 2014
- Date of Event
- February 25, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP, INAPPROPRIATE MODE SWITCHING WAS OBSERVED. THE INAPPROPRIATE MODE SWITCH SEEMED TO BE CAUSED BY R WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270101 | UNIFY CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |