BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3960531 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-23478
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 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 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 PATIENT HAD NOT USED OR CHARGED HER IPG IN APPROXIMATELY 2 YEARS. AS A RESULT, THE IPG WAS INOPERABLE. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE THE IPG WAS REMOVED AND REPLACED WITH A NEW ONE. THE PATIENT REPORTED EFFECTIVE THERAPY POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426576 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2757901

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other SCS LEAD: MODEL 3289| IMPLANT:| SCS EXTENSION: MODEL 3382 (2)