BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3113272 · Received April 25, 2013

    Report

    Report Number
    1627487-2013-05594
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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#: 1627487-2013-05593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180092 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 86228

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention