FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073045
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02295
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- March 25, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. THE FIELD EXPERIENCE WAS NOT CONFIRMED IN THE LABORATORY. A PARTIAL LEAD, 32 CM FROM THE PINS, WAS RETURNED FOR ANALYSIS. WITHOUT THE ENTIRE LEAD, A COMPLETE EVALUATION CANNOT BE PERFORMED. ANALYSIS NOTED AN ABRASION ON THE OUTER INSULATION AT 19.1 CM, CONSISTENT WITH THAT PRODUCED BY FRICTION TO THE ICD CAN. HOWEVER, THE SVC CABLE INSULATIONS WERE NOT ABRADED OR DAMAGED. THE OUTER INSULATION DAMAGE DID NOT CAUSE THE REPORTED HIGH THRESHOLD ISSUE. NO OTHER ANOMALIES WERE FOUND.
Description of Event or Problem · 1
LEAD WAS CAPPED DUE TO HIGH THRESHOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |