FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3210793
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03320
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 17, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC
- 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 THE PATIENT PRESENTED TO THE CLINIC AFTER AN ALERT FOR LOW HV LEAD IMPEDANCE WAS RECEIVED VIA MERLIN.NET. WHEN TESTED IN CLINIC THE LEAD IMPEDANCE WAS NORMAL. INTERROGATION REVEALED NORMAL LIFETIME RANGES, HOWEVER THREE LOW IMPEDANCE READINGS WERE RECORDED THE WEEK PRIOR. THE PATIENT WAS FITTED WITH A LIFE VEST UNTIL REVISION COULD BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310707 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |