FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 4173885
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16727
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 5, 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
- MO, 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 STATES THAT THE ASYMPTOMATIC PATIENT PRESENTED VIA MERLIN TRANSMISSION. ANOTHER INSTANCE OF POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED. PROGRAMMING CHANGES WERE MADE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT FOLLOW UP, POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE. SUBSEQUENTLY, THE POST-PACED T-WAVE OVERSENSING RECURRED AND ADDITIONAL PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654551 | 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 | 57 YR |