BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1050664 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01626
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 6, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS REVEALED AN ABRASION THROUGH THE OUTER COIL INSULATION EXPOSING THE SENSING COIL. THE LEAD ABRASION IS CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE STORED IEGM NOISE WAS DETECTED AS FIBRILLATION. AS A RESULT, THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE;LOW VOLTAGE ALARMS.SPECIFIC COMPONENT(S) INVOLVED: POWER CABLE BROKEN AT CONNECTION.CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED.IMPLANT DEVICE TYPE: LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention