FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3220163
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04253
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- March 8, 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 Location
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD WITH THE ELECTRODE PORTION MEASURING 45.0CM WAS RETURNED. EXTERNAL INSULATION ABRASION WAS FOUND AT 11.0-11. EIGHT CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. EXTERNAL INSULATION ABRASION WAS FOUND AT 43.7-44.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE EFTE COATING WAS INTACT AT THESE LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION. UPON REMOVAL, INSULATION DAMAGE WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321213 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | V-268, 378761, MEDTRONIC 5568, LDN038990V |