FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1050734
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01691
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED MEASURING 51.8CM. ANALYSIS FOUND INTERNAL ABRASION AT MULTIPLE LOCATIONS THROUGHOUT THE LEAD, INCLUDING UNDER THE SHOCK COILS. IN ONE LOCATION, BETWEEN THE RV AND SVC SHOCK COILS, THE RV CABLE EFTE COATING WAS VISIBLE AND ABRADED. HOWEVER, THIS DAMAGE COULD NOT CAUSE THE REPORTED NOISE.
Description of Event or Problem · 1
THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED DUE TO NOISE. DEFIB PORTION REMAINS ACTIVE.
Description of Event or Problem · 1
NEW INFORMATION STATED THAT 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 | Required Intervention |