BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1924452 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03404
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 9, 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. THE EVENT CANNOT BE CONFIRMED THROUGH PRODUCT ANALYSIS LAB TESTING. 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 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: 1627487-2010-03405. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT HIS INCISION SITE. THE PT HAD BEEN TREATED FOR AN UNRELATED INFECTION PRIOR TO HIS IMPLANT DATE, AND HE WAS ALREADY TAKING ANTIBIOTICS AT THE TIME OF HIS IMPLANT. DURING A FOLLOW-UP APPOINTMENT WITH HIS PHYSICIAN, THE PT PRESENTED WITH A FEVER AND GAPING HOLE AT HIS INCISION SITE. THE SCS SYSTEM WAS EXPLANTED ON (B)(6) 2010. THE EXPLANTED DEVICES WERE RETUNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2010. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS ARE UNK AT THIS TIME. THE PT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS. NO FURTHER INFO 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 3158108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R