FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220141
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04628
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- April 6, 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
- MO
- 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 RECEIVED NOTES THAT DURING FOLLOW-UP, POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE AND RESOLVED THE OVERSENSING. PATIENT WAS IN STABLE CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE OVERSENSING WAS NOTED ON A STORED EGM. THE NOISE WAS NOT REPRODUCIBLE WITH ISOMETRICS TESTING. AT A LATER DATE, A MERLIN.NET TRANSMISSION WAS RECEIVED AND SHOWED MYOPOTENTIAL OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320185 | 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 | 67 YR |