BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2812305 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06444
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CALLER NOTED THAT THE DEVICE IS SAYING 96% ATRIAL SENSE - VENTRICULAR SENSE BUT THE HISTOGRAMS DO NOT REPRESENT THAT. ALSO IT SAYS THAT PATIENT IS 50% MODE SWITCHED, BUT THE ATRIAL HISTOGRAM DOES MATCH THAT EITHER. CALLER DISCUSSED THAT THE PATIENT IS IN ATRIAL FIBRILLATION (AF) AND THE ATRIAL HISTOGRAMS IS SHOWING THAT THE DEVICE IS UNDERSENSING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 5076 X2 IMPLANTABLE PACING LEAD