BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2050698 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00514
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPROGRAMMED. UPON INTERROGATION AFTER THE REPROGRAMMING THERE WERE TWELVE VENTRICULAR HIGH RATES NOTED. WHEN TRYING TO INTERROGATE THE SPECIFIC EPISODES AN "INVALID DATA RECEIVED FROM PACEMAKER. GRAPH/DATA CANNOT BE RECEIVED" MESSAGE OCCURRED. 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, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention