BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3925738 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15636
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND THAT THE LEAD EXHIBITED CLAVICULAR CRUSH DAMAGE AT 26.3 CM - 27.4 CM FROM THE CONNECTOR PIN. AN INSULATION ABRASION WAS FOUND AT THIS LOCATION WHICH EXPOSED THE OUTER AND INNER COILS. THE COIL FILARS WERE CRUSHED BUT INTACT. ELECTRICAL TESTING FOUND SHORTING OF THE CONDUCTORS AT THE CLAVICULAR CRUSH REGION WHICH CONTRIBUTED TO THE REPORTED LOW LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE, LOW IMPEDANCE AND LOSS OF SENSING. NOISE WAS REPRODUCED WITH ISOMETRICS. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405283 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 1882TC/52 CWG032699