FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2083844
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-03451
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- January 31, 2011
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND OUTER INSULATION ABRASION AT 8CM FROM THE LEAD TIP. THE INSULATION ABRASION FOUND IS CHARACTERISTIC OF LEAD FRICTION TO ANOTHER DEVICE. THE LEAD WAS RETURNED CUT IN TWO PIECES; HENCE, A COMPLETE ELECTRICAL ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD IMPEDANCE HAD GRADUALLY INCREASED SINCE (B)(6) 2010. THE LEAD WAS LATER EXPLANTED DUE TO INCREASE IN PACING LEAD IMPEDANCE AND CAPTURE THRESHOLDS. INSULATION DAMAGE SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |