BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4151857 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-20281
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 8, 2016
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED SHOCKING SENSATION AT THE IPG SITE WHILE CHARGING. IN TURN, IT CAUSED THE PATIENT TO FALL DOWN AND HURT HIMSELF. AS A RESULT, THE PATIENT REQUESTED AN EXPLANT. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622938 EON SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3716 83884

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT:| SCS LEAD: MODEL 3224