BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 6118164 · Received November 21, 2016

    Report

    Report Number
    1028232-2016-04714
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 8, 2016
    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

    (B)(4). THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED. DURING THE VISUAL INSPECTION, A BEND IN THE DISTAL PART OF THE LEAD WAS NOTED, WHICH CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION. THUS A MECHANICAL ANALYSIS WAS NOT FEASIBLE. BENDING THE LEAD BODY REQUIRES THE PRESENCE OF MECHANICAL STRESS. BASED ON THE DAMAGE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT THE BENDING WAS DUE TO FORCES APPLIED DURING THE SURGERY. FURTHERMORE CUTS IN THE INSULATION WERE OBSERVED WHICH MOST LIKELY RESULTED FROM THE EXPLANT PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REPORTED THAT THIS LEAD LOOKED LIKE IT HAD PULLED OUT OF THE RA VIA XRAY. ALL SENSING AND PACING WAS FINE. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD BUT THE SCREW WOULDN'T RETURN ALL THE WAY INTO THE LEAD DURING THE PROCEDURE SO A NEW LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767592 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization