FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242643
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06145
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 21, 2011
- Report Date
- November 3, 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
- CT
- 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
MANDATORY MEDWATCH FORM WAS RECEIVED. ONLY 54.3CM OF THE ELECTRODE END OF THE LEAD WAS RETURNED. INTERNAL ABRASION WAS FOUND AT 9.7CM TO 10.2CM FROM THE HELIX END. SEVERAL EXTERNAL INSULATION ABRASIONS WERE FOUND BETWEEN 43.7CM TO 45.3CM FROM THE HELIX END. THESE ABRASIONS ARE CONSISTENT WITH FRICTION TO THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED. DURING LEAD EXTRACTION A LEAD FRACTURE WAS NOTED. VISUAL INSPECTION OF LEAD FOUND DAMAGE TO THE PROXIMAL PORTION OF THE SVC COIL. THE CABLES AND FILARS WERE EXPOSED AT THIS LOCATION. 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 | 58 YR | Required Intervention |