BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2100657 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03577
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 ORIGINALLY REPORTED THAT THE PT COULD NOT ADJUST THEIR STIMULATION AND SEE A MESSAGE ON THE PT PROGRAMMER THAT THE DEVICE "WILL SOON CEASE". THE NEUROSTIMULATOR WAS NOTED TO HAVE MALFUNCTIONED AND WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE159603N| EXPLANTED:| LEAD: MODEL 3776, LOT# V613748003| IMPLANTED: