BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 2811823 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06094
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    June 5, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CAPTURE MANAGEMENT OF THE DEVICE HAD INCREASED OUTPUTS. IT IS SUSPECTED THAT THE CAPTURE MANAGEMENT ALGORITHM MAY BE RAISING THE OUTPUTS ON THE VENTRICULAR LEAD AS THE IN OFFICE TESTS INDICATED THE THRESHOLD HAS REMAINED CONSTANT. THE DEVICE REMAINS IN USE AND THE PATIENT WILL BE MONITORED TO DETERMINE IF CAPTURE MANAGEMENT IS INAPPROPRIATELY ADJUSTING THE OUTPUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE'S LONGEVITY ESTIMATE IS ONLY 1.5 YEARS MINIMUM AND 2 YEARS ESTIMATED. THE DEVICE'S OUTPUTS WERE ADJUSTED PER MANUAL THRESHOLDS AND THE VCM (VENTRICULAR CAPTURE MANAGEMENT) TO MONITOR ONLY. THE DEVICE REMAINS IN USE AND THE PATIENT WILL DO A TRANSMISSION IN THREE MONTHS AND AN OFFICE CHECK IN 6 MONTHS. 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 SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL, INC. ADSR06

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD