BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA VDD

    MDR report key: 1792484 · Received August 11, 2010

    Report

    Report Number
    6000094-2010-01484
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 6, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CONCERN ABOUT FAST HIGH RATES OF VENTRICULAR PACING. IT LOOKED LIKE THE DEVICE WAS TRACKING AN ATRIAL ARRHYTHMIA UP TO 130 BEATS PER MINUTE (BPM), THE UPPER TRACKING AND SENSOR RATE AT THE TIME THE STRIP WAS COLLECTED. THE HIGH RATE EPISODE SHOWED THE TRIGGER FOR COLLECTION WAS HIGH RATE, NOT MODE SWITCH. THE CALLER STATED HE IS 98 % CERTAIN MODE SWITCH WAS ON AT THE TIME. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA VDD IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADVDD01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other