BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3890463 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-01384
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE IPG IS TILTED AT AN ANGLE AND AS A RESULT MAKES COMMUNICATION DIFFICULT. (B)(6) TAPE WAS UTILIZED IN AN EFFORT TO KEEP THE ANTENNA STABLE OVER THE IPG. F/U IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 REVISING THE IPG POCKET SITE. POSTOPERATIVE COMMUNICATION WAS ESTABLISHED AND RECHARGING RESUMED TO THE PT'S SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327417 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3547034

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS LEAD: MODEL 3245| IMPLANT DATE: