FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D, DF-4 CONNECTOR
MDR report key: 3943897
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13389
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 17, 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
- TX, 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 DURING FOLLOW-UP, POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE AND RESOLVED THE OVERSENSING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421505 | UNIFY QUADRA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |