BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1962694 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01043
    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
    TX, 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. 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. CONCLUSIONS: 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 REC'D HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE IPG POCKET SITE. IT WAS REPORTED THAT THE PHYSICIAN ATTRIBUTED THE INFECTION TO THE FACT THAT THE PT WAS PICKING AT THE SITE WHICH RESULTED IN PROLONGED HEALING TIME OF THE INCISION. THE PT WAS HOSPITALIZED OVERNIGHT. THE POCKET SITE WAS IMPLANTED WITH A TIME RELEASE COMPOSITE OF VANCOMYCIN. CULTURE RESULTS SHOWED (B)(6). THE PHYSICIAN ONLY EXPLANTED THE IPG. THE IPG EXPLANT DATE IS CURRENTLY UNDETERMINED. F/U ON THE PT FOUND THAT SHE IS BEING TREATED BY AN INFECTIOUS DISEASE PHYSICIAN. A PICC LINE HAS BEEN PLACED, AND THE PT IS BEING TREATED WITH VANCOMYCIN. IT WAS REPORTED THAT THE INFECTION APPEARED TO BE RESOLVING, BUT SOME LEAKAGE HAS BEEN OBSERVED AT THE INCISION SITE WHERE THE IPG WAS EXPLANTED. THE INCISION SITE WAS CULTURED WITH RESULTS PENDING. IT WAS REPORTED THAT ONCE THE INFECTION RESOLVES, THE PHYSICIAN PLANS TO RE-IMPLANT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3788 3170795

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R