FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220047
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04645
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 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
- CT
- 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 EPISODES WERE STORED FOR POST-PACED T-WAVE OVERSENSING VIA A MERLIN.NET TRANSMISSION. FAR-R-WAVE OVERSENSING ON THE ATRIAL CHANNEL WAS ALSO NOTED. PROGRAMMING CHANGES WERE RECOMMENDED. THE DEVICE REMAINS IMPLANTED AND PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321312 | 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 | 51 YR | (B)(4) |