FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1954987
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00092
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 15, 2010
- 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 A COMPLETE ANALYSIS COULD NOT BE PERFORMED DUE TO A PARTIAL LEAD RETURNED MEASURING 49 CM OF THE DISTAL PORTION. ANALYSIS OF THE RETURNED PORTION FOUND INSIDE OUT ABRASION ON THE OUTER INSULATIONS AT 30 CM AND 34 CM FROM THE DISTAL TIP ELECTRODE; THE SENSING CABLES WERE EXPOSED, BUT REMAINED INTACT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DECREASE IN SENSING AND INCREASE IN THRESHOLD WERE OBSERVED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |