BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2844547 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-14035
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 21, 2012
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-14034. THE PT WAS EXPERIENCING A BURNING SENSATION AT HIS IPG SITE. THE PT'S ENTIRE SCS SYS WAS EXPLANTED. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2749486

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention