BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1830440 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03442
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 7, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    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. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE HV THERAPIES. INTERFERENCES COULD BE SEEN ON THE EGM. DURING THE SURGICAL PROCEDURE, INSULATION DAMAGE AT THE TRIFURCATED CONNECTOR WAS OBSERVED, POSSIBLY DUE TO THE TIGHT LIGATURE NEAR AND UNDER THE SUTURE SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention