BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3932221 · Received July 14, 2014

    Report

    Report Number
    1028232-2014-002374
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 2, 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

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM ENDURED A SYNCOPAL EVENT AND HAD A HEART RATE IN THE 30 BPM RANGE. UPON FURTHER REVIEW, OVERSENSING AND LOSS OF CAPTURE WAS NOTED. THE RIGHT VENTRICULAR LEAD PACING IMPEDANCE MEASUREMENTS WERE BELOW 100 OHMS. WHEN PROGRAMMED TO UNIPOLAR SETTINGS, CAPTURE WAS OBSERVED WITH IMPEDANCE MEASUREMENTS OF 200 OHMS. THE PHYSICIAN SUSPECTED THIS WAS A RESULT OF A POSSIBLE INSULATION BREAK. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411082 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization