BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2033603 · Received February 11, 2011

    Report

    Report Number
    1627487-2011-02170
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 17, 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
    NC, US
    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

    DEVICE 1 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-02171 AND 1627487-2011-02172. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. THE PATIENT REPORTED EXPERIENCING A HEATING SENSATION WHEN THE SCS THERAPIES WERE IN USE. ONCE THE THERAPIES WERE DISABLED, THE HEATING SENSATION DISSIPATED. IN ADDITION, THE PATIENT REPORTED HIS STIMULATION COULD NO LONGER BE FELT IN THE DESIRED AREAS. ALTHOUGH ALL IMPEDANCES WERE NORMAL, AN X-RAY OF THE SCS SYSTEM FOUND THAT THE PATIENT'S LEADS HAD MIGRATED. THE SCS SYSTEM WAS REPROGRAMMED AND STIMULATION TO THE DESIRED AREAS WAS RESTORED. REPROGRAMMING WAS UNABLE TO REDUCE THE HEATING SENSATION. THE PATIENT IS CONTINUING TO WORK WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3161511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention