BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1924709 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03399
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    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 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 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: 1627487-2010-03400. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT DEVELOPED AT INFECTION AT HER IPG POCKET SITE. THE SCS SYSTEM WAS EXPLANTED ON (B)(6) 2010. THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2010. A CULTURE WAS TAKEN, BUT THE RESULTS HAVE NOT BEEN DISCLOSED AT THIS TIME. THE PATIENT 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 3153316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention