BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2062191 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02736
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 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
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION TWICE WHILE THE HCP WAS INCREASING THE STIMULATION ON HIS DEVICE. ONE SHOCKING EPISODE CAUSED THE PT TO FALL TO THE GROUND. THE HCP WAS CHECKING THE INS BECAUSE THE PT HAD REPORTED THE INS WAS DEPLETING FASTER THAN IT HAD IN THE PAST. PT HAS ANOTHER APPOINTMENT ON (B)(6) 2011 BUT REQUESTED MFR REP SEE HIM BEFORE THAT, AS HE CANNOT WAIT THAT LONG. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR IMPLANTED:| LEAD: MODEL 3778, LOT # V127456038| ACCESSORY: MODEL 37752, LOT # NKA038000N| LEAD: MODEL 3778, LOT # V127456037| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE111541N| EXPLANTED:| IMPLANTED: