FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3210573
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03475
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 22, 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
- AZ
- 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 NON-SUSTAINED LEAD NOISE DUE TO T-WAVE OVERSENSING WAS NOTED VIA A MERLIN.NET TRANSMISSION. DURING A FOLLOW-UP, POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD WAS OBSERVED. THE PATIENT DID NOT RECEIVE THERAPY. THE OVERSENSING WAS NOTED ON STORED EGMS. THE PATIENT IS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311522 | QUADRA ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |