BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2844512 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-14050
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 24, 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
    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 PT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PT WAS NO LONGER RECEIVING STIMULATION. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTIC TESTS SHOWED INVALID IMPEDANCE. REPROGRAMMING WAS ABLE TO CAPTURE COVERAGE, BUT THE PT IS EXPERIENCING STRONGER STIMULATION IN HER RIGHT LEG. X-RAYS WERE TAKEN AND SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3486455

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT: