FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3090019
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01236
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 27, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED SENSING ANOMALY COULD NOT BE REPRODUCED IN THE LABORATORY. THE DEVICE WAS TESTED USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. NO DEVICE ANOMALY WAS FOUND. THE CAUSE OF THE FIELD OBSERVATION OF A SENSING ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, OVERSENSING WAS OBSERVED WITH A COMPETITOR LEAD. WHEN THE LEAD WAS TESTED WITH A SYSTEM ANALYZER SENSING MEASUREMENTS WERE NORMAL. THE DEVICE WAS REPLACED AND SENSING MEASUREMENTS WERE NORMAL WITH THE NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192351 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3251-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |