BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3810575 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-26382
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    October 1, 2013
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE PT REPORTED SHE IS RECEIVING STIMULATION BUT IF SHE BUMPS THE IPG ON SOMETHING SHE RECEIVES A JOLT OR PAIN. FOLLOW UP INFO REVEALED THE IPG IS AT AN ANGLE OUTWARD WHICH IS BELIEVED TO HAVE CAUSED THE DISCOMFORT. THERE IS NO SKIN IRRITATION OR BREAKDOWN. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271721 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 65333

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other IMPLANT DATE:| SCS RECEIVER, MODEL 3416| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)