BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3366327 · Received September 18, 2013

    Report

    Report Number
    1627487-2013-22029
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 4. REFERENCE MFR. REPORTS # : 1627487-2013-220230, 1627487-2013-220231, 1627487-2013-220232. THE PT HAD TWO LEADS FROM THE SAME LOT. ON (B)(6) 2013, THE PT WAS REPROGRAMMED DUE TO INEFFECTIVE STIMULATION. X-RAYS REVEALED THAT THE LEADS FOR OFF LABEL USE HAD MIGRATED INTO A DIFFERENT LOCATION. ON (B)(6) 2013, THE PT UNDERWENT SURGICAL INTERVENTION TO REPOSITION THE LEAD. THE REPOSITIONING WAS UNSUCCESSFUL DUE TO SCAR TISSUE. IN TURN, THE PHYSICIAN CUT THE LEAD INTO PIECES AND REMOVED WHAT WAS ACCESSIBLE, TO IMPLANT THE NEW LEAD. THE NEW LEAD WAS PROGRAMMED ON (B)(6) 2013 RESULTING IN EFFECTIVE STIMULATION. FOLLOW UP REVEALED SURGICAL INTERVENTION RESOLVED THE PT'S ISSUES. ALL LEADS ARE BEING REPORTED BECAUSE IT IS UNKNOWN WHICH DEVICE HAD MIGRATED AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469732 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3359095

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other IMPLANT:| IMPLANT:| SCS EXTENSIONS, MODEL: 3346 (X2)| IMPLANT:| SCS IPGS, MODEL: 3716 (X2)| SCS EXTENSION, MODEL: 3386