FDA Adverse Event
Malfunction
Summary report: N
QUADRA PLUS EXCELIS CRT-D
MDR report key: 4240728
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17719
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- September 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. THE REPORTED HIGH HV LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE PROGRAMMER REPORT. THE DEVICE WAS TESTED ON THE BENCH, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE HIGH HV LEAD IMPEDANCE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723474 | QUADRA PLUS EXCELIS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3385-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |