BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1950607 · Received December 29, 2010

    Report

    Report Number
    1627487-2010-03989
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY 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

    DEVICE 1 OF 4. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03990, 1627487-2010-03991 AND 1627487-2010-03992. THE PT REC'D HIS SCS SYSTEM CONSISTING OF AN IPG AND SURGICAL LEAD ON (B)(6) 2010. THE PT HAD AN ELECTIVE IPG POCKET SITE REVISION FROM THE BACK TO THE STOMACH, AND HE REC'D TWO EXTENSIONS (FROM TWO SEPARATE LOTS) ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE IPG POCKET SITE. THE PT WAS HOSPITALIZED, AND CULTURE RESULTS SHOWED (B)(6) INFECTION. THE IPG WAS EXPLANTED ON (B)(6) 2010. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PT WAS TREATED WITH IV ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.

    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 3131341

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R