BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 4240544 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004005
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 27, 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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION AT APPROX. 47 CM DISTAL TO THE IS-1 CONNECTOR PIN. THE FINDING CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. FURTHERMORE CUTTINGS IN THE INSULATION WERE FOUND WHICH RESULTED MOST LIKELY 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 RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN PACING INHIBITION FOR LESS THAN TWO SECONDS OF ASYSTOLE. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723018 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization