BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2883783 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02845
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AND A FRACTURED OUTER COIL AT 17.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THESE FINDINGS CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR - FIRST RIB ENTRAPMENT. FURTHER DAMAGES 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 AT A NORMAL FOLLOW UP, THIS LEAD DISPLAYED MUSCLE STIMULATION, DECREASED IMPEDANCES, AND LOSS OF CAPTURE DUE TO HIGH THRESHOLDS. REPROGRAMMING THE LEAD TO A BIPOLAR CONFIGURATION RESOLVED THE ISSUE. AFTER REPROGRAMMING, ONGOING ISSUES WERE NOTED, AND THE LEAD WAS EVENTUALLY EXPLANTED AND REPLACED. AT THE REPLACEMENT PROCEDURE, INSULATION DAMAGE WAS NOTED WHICH WAS SUSPECTED TO BE THE ROOT CAUSE OF THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization