BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3253340 · Received July 29, 2013

    Report

    Report Number
    2938836-2013-04717
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    November 7, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    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

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE PRODUCTS ACTUAL PERFORMANCE AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD NOISE WAS OBSERVED. UPON EXPLANT, THE LEAD BROKE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352984 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention