FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD
MDR report key: 1954875
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00268
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 14, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
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 LEAD WAS REPLACED DUE TO HIGH IMPEDANCE MEASUREMENTS AND INAPPROPRIATE THERAPY. AN ALERT MESSAGE STATING POSSIBLE DEFECT IN OUTPUT CIRCUIT WAS DETECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4)-36, (B)(4) |