FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D
MDR report key: 3220370
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04584
- 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
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 NON-SUSTAINED LEAD NOISE EPISODES DUE TO POST-PACED T-WAVE OVERSENSING WERE CONTINUED. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP AFTER RECEIVING A VIBRATORY ALERT FOR NON-SUSTAINED LEAD NOISE. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM. PROGRAMMING CHANGES WERE RECOMMENDED. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT NON-SUSTAINED LEAD NOISE EPISODES DUE TO POST-PACED T-WAVE OVERSENSING WERE CONTINUED. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319846 | UNIFY ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |