BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2992456 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-05307
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 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 PT HAS TWO LEADS (FROM THE SAME LOT) FOR OFF-LABEL USE. IT WAS REPORTED, THE PT HAD LOST STIMULATION. AN IMPEDANCE CHECK REVEALED LOW IMPEDANCE. ON (B)(6) 2013, THE PT'S LEAD(S) WERE REPOSITIONED. REPOSITIONING THE LEAD(S) RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91565 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3855678

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788