FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3080132
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00974
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 21, 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
A FRACTURE OF THE SENSING COIL WAS FOUND AT 8.2CM FROM THE END OF THE CONNECTOR PIN CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND INAPPROPRIATE SHOCKS.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO LEAD NOISE. AN INCREASE IN PACING LEAD IMPEDANCE AND THRESHOLD WERE OBSERVED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180798 | 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 |