BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 3863273 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11009
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE MEDICAL EQUIPMENT COMPANY REPRESENTATIVE WAS UNABLE TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. AFTER LETTING THE DEVICE "WARM UP IN THE HOUSE", THE DEVICE WAS SUCCESSFULLY INTERROGATED AND THE BATTERY VOLTAGE AND BATTERY IMPEDANCE LEVELS WERE MEASURED. THE DEVICE DATA SHOWED THAT AN ELECTRICAL RESET HAD OCCURRED SEVERAL MONTHS PRIOR. HE WAS ABLE TO CLEAR THE RESET AND REPROGRAM THE DEVICE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340803 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1