BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2212952 · Received August 5, 2011

    Report

    Report Number
    1028232-2011-01732
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT IMPLANTED WITH THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD EXHIBITED TWIDDLER'S SYNDROME. THE LEAD WAS OBSERVED TO HAVE BEEN DISLODGED AND COILED UNDER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). A REVISION PROCEDURE WAS PERFORMED. THE RA LEAD WAS EXPLANTED WITHOUT INCIDENT AND A NEW RA LEAD WAS SUCCESSFULLY PLACED. THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFO BECOME AVAILABLE, OR IF THE LEAD IS RETURNED, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization