BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2092867 · Received May 11, 2011

    Report

    Report Number
    1627487-2011-01503
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    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: 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 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 2. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01504. THE PT REC'D HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION OF THE IPG POCKET SITE. CONSEQUENTLY, THE PHYSICIAN EXPLANTED THE PT'S SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT REC'D INTRAVENOUS ANTIBIOTICS, AND THE IPG POCKET WAS IRRIGATED WITH ANTIBIOTICS. A CULTURE WAS ALLEGEDLY TAKEN; HOWEVER, CULTURE RESULTS ARE UNK. THE FACILITY KEPT THE EXPLANTED DEVICES; THEREFORE, THEY WILL NOT BE RETURNED TO THE MANUFACTURER.

    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 3788 3286207

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R