FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 3101212
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02032
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 11, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 PATIENT PRESENTED TO CLINIC FOR A FOLLOW-UP. INTERROGATION SHOWED ANOTHER NON SUSTAINED LEAD NOISE THAT WAS NOT CAUSED BY T WAVE OVERSENSING. REVIEW OF THE EGMS SHOWED IT WAS DUE TO VARIATIONS IN POINT OF SENSING BETWEEN THE SENSE AMP AND THE DISCRIMINATION CHANNEL. REPROGRAMMING OPTIONS WERE RECOMMENDED. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES AT FOLLOW UP, NON SUSTAINED LEAD NOISE FOR OVERSENSING WAS OBSERVED. MYOPOTENTIAL WAS SUSPECTED. PHYSICIAN ELECTED TO REPROGRAM THE DEVICE AND SET PATIENT UP WITH (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204517 | UNIFY ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |