FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
MDR report key: 4240690
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17714
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 12, 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
- NY, 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
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT PRESENTED INTO CLINIC FOR FOLLOW-UP WHEN POST PACED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED DURING THE DEVICE CHECK.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER NOTIFIER WAS DELIVERED NON SUSTAINED LEAD NOISE. MYOPOTENTIAL OVERSENSING IS SUSPECTED. PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724098 | UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3357-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |