BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031973 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-04391
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    January 20, 2013
    Report Date
    March 8, 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 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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS UNABLE TO FEEL STIMULATION IN BOTH LEGS. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING AND WAS ABLE TO PROVIDE SOME STIMULATION COVERAGE. X-RAYS WERE TAKEN BUT DID NOT REVEAL ANY ANOMALIES. FOLLOW UP IDENTIFIED THE PATIENT HAD ONCE AGAIN LOST STIMULATION COVERAGE. IT WAS REPORTED SURGICAL INTERVENTION WOULD BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127614 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3263518

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788