BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2903094 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-10002
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-10003. IT WAS REPORTED, WHILE CHANGING THE PT'S ((B)(6)) BANDAGE, THE SCS TRIAL CABLE WAS PULLED. LEAD MIGRATION WAS SUSPECTED AND CONFIRMED. THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION TO RESOLVE THE ISSUE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE LEAD ANCHOR WAS IN THE LOCKED POSITION; HOWEVER, THE LEAD CABLE COULD BE STILL BE PULLED THROUGH IT. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD ANCHOR WHICH RESOLVED THE ISSUE. EFFECTIVE STIMULATION WAS ACHIEVED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3420 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3641116

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention