FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3220408
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04261
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 29, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF HIGH LEAD IMPEDANCE WAS NOT CONFIRMED. EXTERNAL INSULATION ABRASION WAS NOTED AT 14.6- 16.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO A FEATURE OF THE HEART. THE ETFE COATING WAS ABRADED AT THE SAME LOCATION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 12.0-14.6CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THE SAME LOCATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO INCREASED PACING LEAD IMPEDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321074 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |