FDA Adverse Event
Injury
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3220159
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04563
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 14, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED SENSING ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE DEVICE WAS EXPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP, POST SENSED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE THERAPY. REPROGRAMMING WAS SUGGESTED AND DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320191 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |