BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1962696 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01042
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE EVALUATION WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED BY PRODUCT TESTING. 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 REC'D HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT HAD BEEN IN AN AUTO ACCIDENT AND BUMPED THE IPG. IT WAS REPORTED THAT THE IPG SITE WAS SORE TO THE PT. THE IPG WAS EXPLANTED AND REPLACED WITH A SMALLER MODEL IPG. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3716 173703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention