BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1925590 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06332
    Event Type
    Malfunction
    Date Received
    December 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 SERIAL NUMBER ON THE DEVICE WAS AT ALL ZEROS AND THE CLINICAL SPECIALIST (CS) WAS INQUIRING WHY. THE CS WAS INFORMED THAT THE DEVICE UNDERWENT A POWER ON RESET (POR) AND THE SERIAL NUMBER DID NOT GET CHANGED BACK TO A NORMAL VALUE. CS WAS ABLE TO PLUG IN THE CORRECT SERIAL NUMBER. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 5076 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD