BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3150042 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-15713
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 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

    DEVICE 2 OF 2: REFERENCE MFR REPORT: 1627487-2013-15712. THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED, THE PT IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. ADDITIONALLY, A COMMUNICATION ERROR MASSAGE APPEARED ON THE PROGRAMMER. THE SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE ISSUE. THE PT STATED HE HAS NOT CHARGED HIS IPG IN APPROXIMATELY 45 DAYS. FOLLOW-UP INFORMATION INDICATED THE X-RAYS WERE TAKEN AND REVEALED THE LEADS HAD MIGRATED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237850 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3389149

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL: 1192 (2)