BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1192071 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06399
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    February 23, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND PAIN FOLLOWING A FALL ON THE ICE ONTO BOTH STIMULATORS. X-RAY CONFIRMED A LEAD MIGRATION AND A REVISION IS SCHEDULED. THE HCP REPORTED THE PT EXPERIENCED NO INJURY. NO FURTHER OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention LOT #NAT149573H| EXPLANTED| LEAD MODEL 3487A LOT# L45706| EXTENSION MODEL 7495-51 LOT# XR0047107N| EXPLANTED| IMPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7425| EXPLANTED| IMPLANTED| LEAD MODEL 3778 LOT# V033221032| IMPLANTED| EXPLANTED| IMPLANTED