BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1922735 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05980
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE PATIENT'S HEART RATE IS NOT INCREASING WITH HIS ACTIVITY AS NEEDED AND THAT THE PATIENT HAS FATIGUE. THE PATIENT WALKED ON THE TREADMILL FOR 11 MINUTES AND HAD LITTLE INCREASE IN HEART RATE AND NO SHORTNESS OF BREATH. THE DEVICE WILL BE REPROGRAMMED TO CHANGE RATE RESPONSE OPTIMIZATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD