BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1940593 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03850
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-03851. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND A SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION OF HER IPG POCKET SITE. AS A RESULT, THE SYSTEM WAS EXPLANTED ON (B)(6) 2010. A CULTURE WAS TAKEN, BUT RESULTS ARE UNKNOWN AT THIS TIME. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. FOLLOW UP ON THE PATIENT FOUND THAT SHE HAS RECOVERED FROM THE INFECTION AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2010.

    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 DIVISION 3788 3185654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention