FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3220363
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04653
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 29, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ONE DAY POST IMPLANT, INTERROGATION REVEALED AN ALERT FOR NONSUSTAINED LEAD NOISE DUE TO UNDERSENSING OF PVCS ON THE DISCRIMINATION CHANNEL. REVIEW OF EGMS SHOWED NO NOISE. DEVICE WAS REPROGRAMMED AND WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320503 | QUADRA ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3267-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |