FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3220177
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04655
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- April 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
NEW INFORMATION NOTES THE DEVICE WAS SUCCESSFULLY REPROGRAMMED. NO FURTHER LEAD NOISE EPISODES NOTED. PATIENT CONDITION WAS VERY GOOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP, NON-SUSTAINTED LEAD NOISE EPISODES AND INAPPROPRIATE MODE SWITCHING WERE NOTED ON THE DEVICE. IT WAS DETERMINED THAT THE NON-SUSTAINED LEAD NOISE WERE CASUSED BY INTERMITTENT CROSSTALK, AND THE MODE SWITCHES WERE CAUSED BY FAR-FIELD R-WAVE OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321292 | 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 |