BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2843458 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02668
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    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: RESULTS: COMPLAINT COULD NOT BE CONFIRMED FOR "PATIENT DID NOT RECHARGE." REVIEW OF DEVICE REGISTERS REVEALED THAT THE IPG WAS FULLY RECHARGED 3 DAYS PRIOR TO EXPLANT. AS RECEIVED, THE IPG BATTERY WAS ALMOST FULL. THE IPG SUCCESSFULLY COMMUNICATED WITH A TEST STANDARD PATIENT PROGRAMMER AND TEST STANDARD CHARGING SYSTEM. THE IPG WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING. 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

    IT WAS REPORTED THE PATIENT'S IPG HAD NO OUTPUT AND WAS REPLACED WITH A DIFFERENT MODEL IPG. IT WAS REPORTED THE IPG DEPLETED DUE TO THE PATIENT NOT RECHARGING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 85669

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1192| IMPLANT:| IMPLANT: