QUADRA ASSURA CRT-D, DF4 CONNECTOR
Report
- Report Number
- 2938836-2013-03502
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 14, 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON AN ASYMPTOMATIC PATIENT VIA A MERLIN.NET TRANSMISSION. THE OVERSENSING WAS NOTED ON A STORED EGM. DEVICE WAS REPROGRAMMED.
NEW INFORMATION RECEIVED STATES THAT THE PRIOR RECOMMENDED PROGRAMMING CHANGES WERE MADE. SUBSEQUENTLY, NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. FURTHER REPROGRAMMING WAS RECOMMENDED.
NEW INFORMATION INDICATED THAT DEVICE POST-PACED T-WAVE OVERSENSING WAS AGAIN OBSERVED. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.
NEW INFORMATION RECEIVED STATES THAT PERSISTENT POST-PACED T-WAVE OVERSENSING WAS OBSERVED VIA A MERLIN.NET TRANSMISSION. THE DEVICE WAS REPROGRAMMED. THE PATIENT CONDITION IS GOOD.
NEW INFORMATION RECEIVED NOTES THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP, POST-PACED T-WAVE OVERSENSING WAS OBSERVED AGAIN ON STORED EGM. PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309585 | 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 | 69 YR |