BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012162 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13262
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 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 HAD TWO TRIAL LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT UNDERWENT A TRIAL PROCEDURE AND WAS IMPLANTED WITH TWO TRIAL LEADS. INTRA-OPERATIVE TESTING CONFIRMED THE PT HAD EFFECTIVE THERAPY. THE PT COMPLAINED OF PAIN AT ONE OF HER LEAD SITES POSTOPERATIVE. THE PT WAS REPROGRAMMED, HOWEVER, THE PAIN CONTINUED TO INCREASE. THE PT'S PHYSICIAN OPTED TO REMOVE THE LEAD, WHICH GAVE THE PT IMMEDIATE PAIN RELIEF. THE PT WAS REPORTEDLY DOING WELL POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106497 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3888985

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention