FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242635
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06124
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 1, 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 ELECTRICAL TESTING OF THE LEAD REVEALED A SHORT CIRCUIT BETWEEN THE PACING AND SENSING COIL. EXTERNAL INSULATION ABRASION WAS FOUND, EXPOSING THE PACING AND SENSING CABLES. THE ABRASION FOUND WAS CONSISTENT WITH FRICTION TO THE ICD CAN. THIS COULD ACCOUNT FOR DECREASED SENSING AND LOW HV IMPEDANCE MEASUREMENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING MANUAL TESTING SOME SIGNALS WERE NOTED ON THE STORED ELECTROGRAMS. BOTH LEADS SHOWED A DECREASE IN IMPEDANCE. SENSING HAD DECREASED IN THE VENTRICLE. LEAD DAMAGE SUSPECTED. 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 | 1999/52 (B)(4) |