FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3220017
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04347
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 31, 2013
- 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 EXTERNAL INSULATION ABRASION WAS NOTED AT 14.2-14.8CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INTERROGATION, NOISE WAS DETECTED AS VF/VT AND AF/AT. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320216 | 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 |