FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1223392
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03671
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED SENSING ANOMALY WAS CONFIRMED. AS RETURNED, THE SHAFT INSIDE THE HEADER AND RING ELECTRODE WERE SLIGHTLY SEPARATED, WHICH CAUSED FRACTURE OF THE INNER COIL. IT WAS NOT DETERMINED IF THE DAMAGE OCCURRED DURING MANUFACTURING OR IN THE FIELD.
Description of Event or Problem · 1
IT WAS REPORTED THAT NO SENSING OR PACING WAS OBSERVED. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |