BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1223467 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03637
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 13, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THE PHYSICIAN HAD TO REPOSITION THE LEAD MULTIPLE TIMES TO FIND A GOOD LOCATION FOR PACE/SENSE VALUES. THE PHYSICIAN NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE, AND THE PATIENT SHOWED SYMPTOMS OF CARDIAC TAMPONADE. FLUOROSCOPY REVEALED THAT THE LEAD TIP HAD PERFORATED THE VENTRICULAR WALL. THE LEAD TIP WAS PULLED BACK, AND WAS SECURED IN A NEW LOCATION. ECHOCARDIOGRAM SHOWED NO ACCUMULATED FLUID IN THE PERICARDIAL S PACE.

    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 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention