FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2242703
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06031
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 2, 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 Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED SEVERAL EXTERNAL INSULATION ABRASIONS. THE SVC AND RE-CABLES WERE EXPOSED IN THESE ABRASION ZONES, BUT THE ETFE COATING WAS NOT COMPROMISED. THESE DAMAGES ARE CONSISTENT WITH FRICTION TO THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN X-RAY REVEALED LEAD FRACTURE. INSULATION DAMAGE WAS NOTED. LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |