FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR
MDR report key: 4130786
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16135
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- September 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SE
- Reporter Occupation
- NURSE
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 A NONSUSTAINED OVERSENSING ALERT WAS OBSERVED DUE TO T-WAVE OVERSENSING. REPROGRAMMING CHANGES WERE MADE. THE PATIENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608422 | QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3367-40QC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |