BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2040927 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02236
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 9, 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).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. ON (B)(6) 2011, IT WAS REPORTED THE PT'S DEVICE SHOWED HIGH IMPEDANCE READINGS. IT WAS STATED ALL ELECTRODE CONTACTS SHOWED IMPEDANCES >3,600 OHMS. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. IT WAS STATED THE PT WAS SCHEDULED FOR REVISION OF THEIR DEVICE. 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 RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD022667N| PROGRAMMER: MODEL 7435, LOT# NFT042726P| LEAD: MODEL 3776, LOT# V006143| EXTENSION: MODEL 7489, LOT# NHU029109V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU036088V| PROGRAMMER: MODEL 7439, LOT# NJD015431N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V003397| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: