FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1830669
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03347
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 17, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- 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
THE REPORTED INSULATION BREAK WAS CONFIRMED. THE OUTER INSULATION WAS ABRADED BETWEEN 16.7CM AND 17.2CM FROM THE CONNECTOR PIN AND THE SENSING CABLE WAS ABRADED AND EXPOSED OUTSIDE THE INSULATION. THE DAMAGE FOUND IS CONSISTENT WITH THAT OF FRICTION TO THE ICD CAN. ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING A BATTERY INDICATOR ISSUE WITH THE METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Description of Event or Problem · 1
THE PATIENT RECEIVED SEVERAL VF EPISODES WITHOUT SHOCK THERAPY. DURING EXPLANT, INSULATION BREAK WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |