BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2061835 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-02555
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MDTPUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION "ONCE IN A WHILE" THAT TRAVELED DOWN THE RIGHT LEG. THE PT HAD LOST 180 POUNDS IN THE LAST 18 MONTHS, WHICH HAS CAUSED THE IMPLANTABLE NEUROSTIMULATOR TO "BOUNCE AROUND IN THE BODY" AND "NOT WORK AS WELL." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3777, LOT# N0040744| PROGRAMMER: MODEL 37742, LOT# NJD020181N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005862N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005797N| LEAD: MODEL 3777, LOT# J0546742V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: