FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2242926
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06440
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- July 29, 2011
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE PROXIMAL 26.5CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 11.0-11.7CM FROM THE END OF THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HOLTER SHOWED EPISODES OF OVERSENSING, INCREASED CAPTURE THRESHOLDS AND DECREASED IMPEDANCE.
Description of Event or Problem · 1
NEW INFORMATION PROVIDED INDICATED THAT NOISE WAS OBSERVED ON ECG. THE LEAD WAS CAPPED. THE PATIENT IS IN GOOD CONDITION AFTER REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |