BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110639 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-08063
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-08064. IT WAS REPORTED, THE PT STOPPED USING AND RECHARGING THE IMPLANTED SYSTEM SINCE 2012. IT WAS STATED, THE DEVICE WAS NOT PROVIDING THE SAME ADEQUATE STIMULATION AS THE TRIAL SYSTEM PROVIDED. THE PT WAS ALSO EXPERIENCING PAIN AT THE DISTAL END OF THE LEAD SITE EVEN THOUGH THE SYSTEM HAD BEEN POWERED OFF FOR ABOUT A YR. IT WAS REPORTED, HE FELT THE POCKET WAS SLIPPING DOWNWARD, PULLING ON LEAD WIRES CAUSING PAIN AND NUMBNESS IN HIS HEAD. THE PT WANTED THE SYSTEM TO BE EXPLANTED AND NO FURTHER INFO WAS AVAILABLE A THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205170 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3175257

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention