BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1830579 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03427
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6)2010, A RISE IN THRESHOLD WAS OBSERVED. X-RAY REVEALED ANOTHER LEAD DISLODGEMENT. THE LEAD WAS CAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING MULTIPLE SHOCKS. THE LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention