FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3210574
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03476
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 2, 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
- OR
- 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 TO THE CLINIC FOR A ROUTINE FOLLOW-UP WITH A DEVICE THAT WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE INAPPROPRIATE HV THERAPY. THE OVERSENSING WAS NOTED ON A STORED EGM. PROGRAMMING CHANGES WERE MADE TO THE DEVICE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309046 | 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 | 57 YR |