BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3820961 · Received May 8, 2014

    Report

    Report Number
    1627487-2014-05327
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 17, 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 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2014-05328. IT WAS REPORTED, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AT THE IPG SITE. THE PATIENT WAS ALSO UNABLE GAIN COMMUNICATION WITH THE IPG VIA THE EXTERNAL DEVICES. IT WAS ALSO REPORTED, THE PATIENT WAS RECEIVING INADEQUATE COVERAGE. IN TURN, THE LEAD WAS FOUND TO BE FRACTURED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, THE DOCTOR EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO EXPLANT THE LEAD DUE TO SCAR TISSUE. THE DOCTOR DECIDED TO CUT AND REMOVE THE LEAD TAILS AND LEAVE THE PADDLE PORTION OF THE LEAD IMPLANTED. REGARDLESS, ANOTHER LEAD (DIFFERENT MODEL) WAS IMPLANTED. THE IPG WAS ALSO EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279126 EON SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3716 65096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other