BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2023075 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01393
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE (OUT OF THE BOX), THE NEUROSTIMULATOR SHOWED A POWER-ON-RESET (POR) CONDITION MESSAGE ON BOTH THE PATIENT AND CLINICIAN PROGRAMMERS. THE POR COULD NOT BE CLEARED SINCE THE DEVICE WOULD HAVE TO BE PROGRAMMED FIRST AND THIS WAS NOT DONE SINCE THE PROCEDURE HAD NOT BEGUN. A NEW NEUROSTIMULATOR WAS THEN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED TO OBTAIN PATIENT OUTCOME INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1