BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1915308 · Received November 2, 2010

    Report

    Report Number
    1627487-2010-03508
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 INFORMATION 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 HIS SCS SYSTEM, INCLUDING A RECHARGEABLE IPG, ON (B)(6) 2008. IT WAS REPORTED THE IPG IMPLANT SITE SUDDENLY BECAME HOT WHEN THE IPG WAS RECHARGED. THE PT WAS GIVEN A NEW DEVICE CHARGER. FOLLOW UP ON THE PT FOUND THAT THE NEW CHARGER CORRECTED THE ISSUE. THE IPG REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 97742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention