BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2172593 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06011
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 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

    EVAL: 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 INFO 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 RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S IPG POCKET WAS SORE AND OOZING. FURTHER INTERROGATION OF THE IMPACTED SITE REVEALED A SEROMA. THE IPG POCKET WAS IRRIGATED, AND THE SEROMA PARTIALLY REMOVED. BOTH INTRAVENOUS AND ORAL ANTIBIOTICS WERE ADMINISTERED TO THE PT AS TREATMENT. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS HAVE NOT BEEN DISCLOSED. THE PT IS RECOVERING, AND HER IPG REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3319782

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R SCS LEAD ANCHOR: MODEL 1192 (2)| IMPLANTED:| SCS LEAD: MODEL 3228| IMPLANTED: