BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3231537 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-10228
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE PT (NETHERLANDS) EXPERIENCED A SUDDEN LOSS OF STIMULATION FOLLOWED BY POCKET HEATING THAT OCCURS APPROX 10-15 MINUTES LATER. THE PT REPORTED THE IPG BECOMES SO WARM, HE HAS TO TURN STIMULATION OFF. ONCE THE IPG HAS COOLED DOWN, STIMULATION IS POSSIBLE UNTIL THE EVENT OCCURS AGAIN. EFFORTS TO RESOLVE THE ISSUE VIA REPROGRAMMING WERE UNSUCCESSFUL. DIAGNOSTIC TESTING AND X-RAYS WERE PERFORMED WITH NO ANOMALIES NOTED. THE IPG WAS EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323706 EONC SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3688 3400034

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS LEAD: MODEL 3286| IMPLANT DATE:| SCS LEAD EXTENSION: MODEL 3386| SCS LEAD ANCHOR: MODEL 1194| IMPLANT DATE:| IMPLANT DATE: