BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3021811 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00741
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 11, 2013
    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

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE CUTTINGS IN THE INSULATION OCCURRED MOST LIKELY DURING THE SURGERY. 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 LEAD EXHIBITED NOISE AND OVERSENSING. THE PATIENT HAD BEEN NAUSEOUS SINCE IMPLANT AND THE PHYSICIAN WAS SURE IT WAS A LEAD ISSUE. THE PATIENT WAS PREPPED AND THE POCKET OPENED WHEN THE FIELD REPRESENTATIVE ARRIVED. THE FIELD REPRESENTATIVE REVIEWED THE LOGBOOK AND THINKS IT LOOKED LIKE "EMI, OTHER NUMBERS WERE FINE, CONNECTIONS WERE GOOD". THE LEAD WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124783 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization