BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2141127 · Received June 22, 2011

    Report

    Report Number
    3004209178-2011-04663
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S INFECTION AT THE DEVICE SITE BEGAN IN 2010, A YEAR AFTER THE IMPLANTATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS REMOVED IN (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSP DUE TO AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR SITE. 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 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA118259N| LEAD: MODEL 3487A, LOT# V129426| LEAD: MODEL 3487A, LOT# V129426| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE130996N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB015667N