BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2191939 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05687
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    November 1, 2010
    Report Date
    June 28, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDISCHARGE OCCURRED. IT WAS REPORTED THAT THE PT TRIED TO VISIT THEIR DOCTOR CONCERNING THIS ISSUE BUT COULD NOT BE SEEN BECAUSE HE OWED A LARGE AMOUNT OF MONEY TO THE OFFICE. IT WAS REPORTED THE PT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY. THE PT LET THEIR BATTERY DISCHARGE NUMEROUS TIMES AND NOT IT IS DEAD. THE PT WAS SEEKING ANOTHER HCP BUT IT WAS DIFFICULT TO FIND SINCE THE PT HAS BEEN NON-COMPLIANT USING THE THERAPY AND UNWILLING TO PAY HIS OUTSTANDING DEBT.

    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 54 YR PROGRAMMER: MODEL 37742, LOT# NJD011250N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC000774N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V001871| EXTENSION: MODEL 37083, LOT# NKC003833N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: