BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 3923530 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14784
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND EXTERNAL INSULATION ABRASION AT 33.8 TO 34.1 CM FROM THE DISTAL END OF THE LEAD. THE DAMAGE WAS CONSISTENT WITH CONSTANT FRICTION BETWEEN THE LEAD AND DEVICE BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE ATRIAL LEAD AS A RESULT OF CLAVICULAR CRUSH DAMAGE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400314 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention