BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC IMPLANTABLE PULSE GENERATOR

    MDR report key: 2050926 · Received April 4, 2011

    Report

    Report Number
    1627487-2011-02398
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    February 20, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT ((B)(6)) RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE IPG WAS EXPLANTED DUE TO A LOSS OF STIMULATION AND UNACCEPTABLE IMPEDANCES. INTRAOPERATIVE TESTING THE IMPLANTED LEAD FOUND ACCEPTABLE IMPEDANCES; THE PHYSICIAN WAS UNABLE TO PROVIDE ANY STIMULATION FOR THE PATIENT VIA THE IMPLANTED LEAD. THE MANUFACTURER, MODEL AND SERIAL NUMBERS WERE NOT PROVIDED; THEREFORE, NO REPORT HAS BEEN SUBMITTED FOR THE PATIENT'S IMPLANTED LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3194969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention