BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3891470 · Received June 24, 2014

    Report

    Report Number
    1028232-2014-002125
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    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

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. DURING THE VISUAL INSPECTION A BEND IN THE LEAD'S DISTAL PART WAS NOTED. BENDING THE DISTAL PART REQUIRES THE PRESENCE OF MECHANICAL STRESS. TENSILE FORCES DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, A BEND IN THE LEAD'S DISTAL PART WAS NOTED. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS DUE TO DISLODGEMENT. UPON LEAD REVISION, THE PHYSICIAN NOTICED THERE WAS INSULATION DAMAGE. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368642 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization