BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1900474 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-03125
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO 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 HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT HIS STIMULATION IS INEFFECTIVE AND THAT THE RECHARGING INTERVALS FOR HIS IPG ARE TOO FREQUENT. THE USE OF A REPLACEMENT CHARGING SYSTEM PROVED UNSUCCESSFUL IN RESOLVING THE REPORTED CHARGING ISSUE. F/U ON THE PT FOUND THAT HE WAS RECENTLY REPROGRAMMED TO LOWER SETTINGS IN HOPES OF INCREASING THE TIME SPAN BETWEEN RECHARGES. RESULTS OF THAT INTERVENTION METHOD ARE PENDING. NO SURGICAL INTERVENTION HAS BEEN PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3108396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention