BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3161715 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-04716
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 2 OF 3. REF MFR REPORTS: 1627487-2013-04715 AND 04717.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249112 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3186 3185461

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention