BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3171956 · Received June 10, 2013

    Report

    Report Number
    1627487-2013-03784
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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 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

    THE PATIENT RECEIVED 2 SCS TRIAL LEADS. IT WAS REPORTED DURING THE PATIENT'S TRIAL PROCEDURE, ONE OF THE SCS LEADS SHOWED INVALID IMPEDANCE VALUES WHEN CONNECTED INTO THE MTS. SUBSEQUENTLY, A DIFFERENT SCS LEAD WAS USED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261627 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 4003077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention