BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION IMPLANTABLE PULSE GENERATOR

    MDR report key: 2434728 · Received January 30, 2012

    Report

    Report Number
    2434728
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS POST-LAMINECTOMY SYNDROME, AND THE STIMULATOR WAS MALFUNCTIONING. ACCORDING TO THE SURGEON'S HISTORY AND PHYSICAL "HER STIMULATOR HAD RUN DOWN." THE PATIENT DID INDICATE SHE HAD COVERAGE DOWN TO THE FOOT, BUT NOT INCLUSIVE OF THE FOOT. THE PATIENT THEN UNDERWENT REMOVAL AND REPLACEMENT OF THE SPINAL GENERATOR. ACCORDING TO THE OP NOTE: "PREVIOUS PULSE GENERATOR WAS DISSECTED FREE FROM SURROUNDING TISSUES. IT WAS DISCONNECTED FROM THE STIMULATOR. A NEW PULSE GENERATOR WAS CONNECTED TO THE STIMULATOR. IMPEDANCES WERE CHECKED AND FOUND TO BE NORMAL". THE PATIENT WAS THEN TAKEN TO RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION IMPLANTABLE PULSE GENERATOR STIMULATOR, SPINAL-CORD, IMPLANTED, PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NO OTHER THERAPIES