BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1062276 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-03328
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL AND DAMAGED THE DEVICE. THE PATIENT EXPERIENCED PAIN AND SENSITIVITY AROUND THE AREA. COUPLING AND/OR COMMUNICATION ISSUES WERE REPORTED. THE DEVICE BATTERY WAS DISCHARGED. THE PATIENT LOST STIMULATION. THE MANUFACTURER REPRESENTATIVE CONFIRMED THE PATIENT RECHARGER WORKED WITH A DIFFERENT NEUROSTIMULATOR. AN XRAY WAS SUGGESTED TO DETERMINE IF THE NEUROSTIMULATOR WAS FLIPPED. THE NEUROSTIMULATOR FLIPPED SEVERAL TIMES; THE PLAN WAS TO SUTURE IN THE NEUROSTIMULATOR AND PERHAPS REPLACE THE LEADS. THE NEUROSTIMULATOR WAS REPLACED.

    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 77 YR Required Intervention IMPLANTED:| RECHARGER SYSTEM: MODEL 37752 LOT# NKA023704N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778 LOT# V074883001| IMPLANTED:| LEAD: MODEL 3778 LOT# V073951039| EXPLANTED:| EXPLANTED: