BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3072359 · Received April 18, 2013

    Report

    Report Number
    1627487-2013-05556
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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 1 OF 3. REFERENCE MFR. REPORT#: 1627487-2013-0557, 05558. THE PT HAD TWO ANCHORS (FROM THE SAME LOT). IT WAS REPORTED THE PT WAS NOT RECEIVING ADEQUATE STIMULATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. X-RAYS REVEALED BOTH OF THE PT'S LEADS HAD MIGRATED. ON (B)(6) 2013, THE LEADS WERE REPOSITIONED AND THE ANCHORS WERE EXPLANTED AND REPLACED. REPOSITIONING THE LEADS RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167834 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3903733

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788