BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 4240529 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004009
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 27, 2014
    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 LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE DISTAL PART OF THE LEAD AS WELL AS THE FIXATION HELIX WERE FOUND BENT. BENDING THE LEAD BODY REQUIRES THE PRESENCE OF MECHANICAL STRESS. TENSILE FORCES APPLIED DURING THE SURGERY SHOULD BE TAKEN INTO ACCOUNT AS THE ROOT CAUSE OF THESE DAMAGES. FURTHER ANALYSIS REVEALED CUTTINGS IN THE INSULATION. THESE DAMAGES OCCURRED MOST LIKELY DUE TO MEDICAL INSTRUMENTS USED DURING THE SURGERY. WITH REGARD TO THE ISSUE MENTIONED IN THE COMPLAINT DESCRIPTION, NO IRREGULARITIES WERE FOUND. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED. ANOTHER LEAD WAS IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723013 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization