BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110842 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-05648
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 1, 2010
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    DEVICE 1 OF 3. REFERENCE MFR. REPORTS: 1627487-2013-05647 AND 1627487-2013-05649. IT WAS REPORTED THE PT'S IPG WAS EXPLANTED IN 2010 DUE TO OVERSTIMULATION AND NOT RECEIVING PAIN RELIEF. IT IS UNK IF AN SJM REP WAS MADE AWARE OF THE PROCEDURE OR IN ATTENDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204768 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 171869

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention