BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211152 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06150
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR HAD NOT BEEN CHARGED IN ABOUT TWO MONTHS. AN INS OVERDISCHARGE WAS SUSPECTED. THIS WAS THE PT'S SECOND OVERDISCHARGE. ON (B)(6) 2011, THE PT ATTEMPTED THREE PHYSICIAN MODE RECHARGES, BUT NEVER GOT TO THE NORMAL RECHARGING SCREEN. THE ANTENNA LOCATE FEATURE ALSO FAILED TO RESOLVE THE ISSUE. ADD'L INFO RECEIVED REPORTED THAT THE PT WAS UNABLE TO CHARGE THE INS AND WILL SCHEDULE A REVISION TO RECEIVE A NEW INS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR PROGRAMMER: MODEL 37743, LOT# NKE116909N| ACCESSORY: MODEL 37752, LOT# NKA118613N| LEAD: MODEL 3998, LOT# L73354| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB014568N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005594N| EXPLANTED:| EXPLANTED: