BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940462 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-02438
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    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
    NOT APPLICABLE

    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

    IT WAS REPORTED DURING THE PATIENT'S SURGERY FOR REPLACEMENT OF HIS SCS IPG (REF. MEDWATCH REPORT #1627487-2014-15091), THE PHYSICIAN WAS GOING TO REPLACE THE PATIENT'S LEADS. HOWEVER, DUE TO SCAR TISSUE THE PHYSICIAN WAS ONLY ABLE TO IMPLANT ONE OF THE LEADS. THE PROCEDURE WAS REPORTEDLY EXTENDED B APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357614 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION 3186 4332603

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other