BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 1230535 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07410
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. A LOW BATTERY WAS DIAGNOSED. THE STIMULATOR WAS REPLACED DUE TO THE LOW BATTERY. AFTER BATTERY REPLACEMENT, THE PATIENT WASN'T GETTING PARESTHESIA. THE LEAD WAS INVESTIGATED. UPON REMOVAL OF THE LEAD FROM THE EXTENSION, IT WAS DISCOVERED THAT THE EXTENSION SCREWS HAD POSSIBLY BEEN OVER TIGHTENED AND PLACED BETWEEN THE ELECTRODE PLATES. THE LEAD AND EXTENSION WERE REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD MODEL: 3847A| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495| IMPLANTED: