BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 1884085 · Received October 21, 2010

    Report

    Report Number
    1627487-2010-03066
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2007, IT WAS REPORTED THAT HIS IPG ERODED THROUGH THE SKIN. THERE WAS NO INDICATION OF INFECTION. THE PATIENT'S IPG AND LEAD WERE EXPLANTED ON (B)(6) 2010, BUT HE WILL NOT RECEIVE A REPLACEMENT SYSTEM. FOLLOW-UP ON THE PATIENT FOUND NO ADDITIONAL ISSUES REPORTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL, NEUROMODULATION DIVISION 3716 69566

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention