BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 3241158 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01964
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS DEMONSTRATED SEVERE DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. THESES DAMAGES WERE CAUSED BY OVERROTATION OF THE INNER COIL WHILE RETRACTING THE FIXATION MECHANISM. THE DEFORMATION OF THE FIXATION HELIX OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING POCKET REVIEW POST-IMPLANT, THIS LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND A NEW PASSIVE FIXATION LEAD WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340485 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization