BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3960203 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-23483
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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

    IT WAS REPORTED THE PT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. IT WAS ALSO REPORTED THE PT HAD NOT CHARGED HER IPG IN OVER A YEAR. AS A RESULT, THE IPG WAS INOPERABLE. SUBSEQUENTLY, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE THE IPG WAS REMOVED AND REPLACED WITH A NEW ONE. THE PT REPORTED EFFECTIVE THERAPY POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429803 EON SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3716 50519

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186