BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1930113 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03596
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE IPG WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. AS A RESULT, THE DEVICE HISTORY AND STERILIZATION RECORDS FOR THE IPG ARE CURRENTLY UNDER REVIEW. THE RESULTS OF THE REVIEW WILL BE FORWARDED WHEN AVAILABLE. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS 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 ((B)(6)) RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THE PT CONTINUED TO FEEL STIMULATION IN HER FEET EVEN AFTER SHE TURNED THE SCS THERAPIES OFF. THE PT USES HER PT PROGRAMMER TO TURN THE DEVICE ON AND OFF AND THE PHYSICIAN HAS REPLACED THE PT'S PROGRAMMER ON THREE SEPARATE OCCASIONS. UNFORTUNATELY, THE PROBLEM PERSISTS. AS THE PHYSICIAN SUSPECTS THE INTERFERENCE BETWEEN THE PT'S PROGRAMMER AND SOMETHING IN HER HOME, THE IPG REMAINS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 2812095

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention