BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2890201 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10579
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 25, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS WAS NORMAL. NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 11.5-12.1CM AND 12.7-12.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNAL INSULATION ABRASION WAS NOTED AT 15.8-16CM A ND 37-38.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. EXTERNAL ABRASION WAS NOTED AT 44.9-45.6CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE EFTE COATING WAS INTACT AT THESE LOCATIONS..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE OR FOR CHANGE OUT DUE TO NORMAL ERI. AN INSULATION ABRASION DISTAL TO THE YOKE AND PROXIMAL TO THE SUTURE SLEEVE WAS OBSERVED UPON EXPLANT. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASYMPTOMATIC PATIENT PRESENTED IN THE ER FOR A NORMAL FOLLOW-UP. NO ELECTRICAL ANOMALIES WERE DETECTED. DURING EXPLANT, EXTERNALIZED CONDUCTORS WERE OBSERVED, AT THE DISTAL YOKE AND PROXIMAL TO THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED.

    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 83 YR