BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 3243258 · Received July 23, 2013

    Report

    Report Number
    1028232-2013-00550
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    December 18, 2012
    Report Date
    February 21, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS SHOWED CUTTINGS IN THE INSULATION, DEFORMATION OF THE INNER AND OUTER COIL AS WELL AS A BENT FIXATION HELIX. THESE DAMAGES REQUIRE THE PRESENCE OF MECHANICAL STRESS. TRACTION FORCES DURING THE EXPLANT PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFO THAT THIS RIGHT VENTRICULAR LEAD GOT DISLODGED A FEW WEEKS AFTER IT WAS IMPLANTED DUE TO TRICUSPID REGURGITATION. THE PHYSICIAN SUCCESSFULLY IMPLANTED ANOTHER LEAD IN THE RIGHT VENTRICLE AND THIS LEAD WAS EXPLANTED AND NO LONGER USED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343320 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization