BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2050046 · Received March 31, 2011

    Report

    Report Number
    3007566237-2011-02456
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 14, 2011
    Report Date
    July 29, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE INS WAS INTERROGATED PRIOR TO THE CASE AND A WARNING CAME UP THAT THERE WAS AN "INVALID SERIAL NUMBER". THE INS WAS GOING TO BE RETURNED TO THE DEVICE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown