BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PULSE GENERATOR

    MDR report key: 2020440 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-02154
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE PT CAN NO LONGER ESTABLISH TELEMETRY BETWEEN HER IPG AND CHARGING SYSTEM. THE PT IS CURRENTLY WITHOUT STIMULATION AS HE HAS NOT CHARGED HIS IPG IN OVER A MONTH. A NEW CHARGING SYSTEM WAS SENT TO THE PT. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3166009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention