BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1870746 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07881
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    April 6, 2006
    Report Date
    February 13, 2009
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, IT WAS REPORTED THAT THE PT NO LONGER HAD ADEQUATE PARESTHESIA COVERAGE AND THE IMPEDANCE OF ONE HALF OF THE ELECTRODES WAS ABNORMALLY HIGH. THE DEVICE WAS REPROGRAMMED "MANY" TIMES OVER A PERIOD OF "SEVERAL" DAYS, BUT THIS DID NOT RESOLVE THE PROBLEM. AN X-RAY WAS TAKEN REVEALING THERE WAS NO DISCONTINUITY OF THE SYSTEM, BUT THE EPIDURAL ELECTRODE WAS LOWER THAN PREVIOUSLY. THIS WAS NOT UNEXPECTED SINCE IT WAS INTENTIONALLY PLACED LOWER. BEFORE A REVISION COULD BE PERFORMED, THE PT'S PAIN BECAME INTOLERABLE, AND THE PT WENT TO THE EMERGENCY ROOM FOR EMERGENCY PAIN MGMT. THE PT WAS ADMITTED FOR PARENTERAL MEDICATION THERAPY OF HIS REFRACTORY PAIN CONDITION . THE DEVICE WAS REVISED AND THE PT EXPERIENCED PAIN RELIEF AND PARESTHESIA COVERAGE THAT WAS "BETTER THAN EVER". FOR INFO ABOUT EVENTS THAT OCCURRED BEFORE THE IMPLANT, SEE MFR REPORT # 3004209178-2010-07879.

    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 47 YR Hospitalization| R EXTENSION: MODEL 37083, LOT# NKC006621N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# J0437134V| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD022094N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC006620N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA017140N| IMPLANTED:| IMPLANTED: