BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 908436 · Received September 5, 2007

    Report

    Report Number
    3004209178-2007-02847
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    July 1, 2007
    Report Date
    August 10, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECHARGED SINCE IMPLANT WITH NO ISSUES. TEN DAYS AGO, THE PATIENT FELT A PINCHING SENSATION IMMEDIATELY AFTER PUTTING THE BELT ON AND STARTING THE RECHARGING PROCESS (THE PATIENT WAS SEATED DURING THE RECHARGING). THE PATIENT REPORTED FEELING HIS SKIN HEATING UP AND NOTICED THERE WAS REDNESS WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS. THE HCP CONFIRMED THAT THERE APPEARED TO BE A THERMAL BURN ON THE SKIN OVER THE LOWER RIGHT HAND CORNER OF THE INS WHERE THE INS WAS MORE SUPERFICIAL. THE TWO SMALL AREAS WITH THE BURN SCARRED OVER. THE PATIENT WAS INSTRUCTED TO USE A SPACER AND THE PATIENT HAD RECHARGED AGAIN WITH NO ISSUES. SEE MANUFACTURER'S REPORT NUMBER: 6000031-2007-02558. IT WAS FURTHER REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED| LEAAD MODEL 3998 LOT# V003187| IMPLANTED| RECHARGER MODEL #3775201ID LOT # NKA027105N| IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 3708360AA LOT# NKC005409N| IMPLANTED| IMPLANTED| EXTENSION MODEL 3708360AA LOT# NKC007331N| EXPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 37742AA LOT# NJD020778N