FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220375
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04627
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 31, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE OVERSENSING WAS NOTED ON A STORED EGM. THE DEVICE WAS REPROGRAMMED. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT A MERLIN TRANSMISSION DISPLAYED NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE, SUBSEQUENTLY HOWEVER AN ADDITIONAL REMOTE TRANSMISSION REVEALED NONSUSTAINED RV OVERSENSING ALERTS. THE PATIENT WILL CONTINUE TO BE MONITORED REMOTELY. THE PATIENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320539 | QUADRA ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |