FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 4240735
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17713
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- September 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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 POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED VIA MERLIN.NET TRANSMISSION. REVIEW OF STORED ELECTROGRAMS CONFIRMED OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT CONDITION WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724206 | QUADRA ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3365-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |