BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 5210998 · Received November 9, 2015

    Report

    Report Number
    1028232-2015-04080
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 1, 2015
    Report Date
    October 26, 2015
    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 INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACE IMPEDANCE OF > 2000 OHMS AND TRIPPED THE LEAD SAFETY SWITCH. NOISE HAS BEEN SEEN SINCE THE LSS. THE RV LEAD WAS PROGRAMMED TO SENSE IN BIPOLAR AND PACE IN UNIPOLAR AS THOSE PROGRAMMED PARAMETERS PROVIDED THE BEST MEASUREMENTS. THE LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741420 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization