BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1895446 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03165
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT HER IPG WAS SHUTTING OFF RANDOMLY. IN ADDITION, THE RECHARGE INTERVALS FOR THE DEVICE HAD INCREASED. AFTER AN ATTEMPT TO RESOLVE THESE ISSUES THROUGH NONINVASIVE MEANS, THE PT'S IPG WAS REMOVED AND REPLACED ON (B)(6) 2010. F/U ON THE PT FOUND THAT SHE IS DOING WELL WITH NO NEW ISSUES REPORTED. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR ON (B)(6) 2010.

    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 172715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention