BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1854743 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04425
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT "HER DEVICE IS GOING TOO FAST" AND THAT SHE HAS HAD "DIZZINESS AND PASSED OUT". THE PATIENT STATES HER PHYSICIAN WANTS TO TREAT HER WITH MEDICATION AND WILL NOT "ADJUST THE DEVICE". THE PATIENT STRESSED THAT THE DEVICE IS "NOT WORKING RIGHT". THE DEVICE REMAINS IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 4092 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD