BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6153163 · Received December 7, 2016

    Report

    Report Number
    1627487-2016-06313
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 18, 2016
    Report Date
    March 10, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION FOR A POCKET REVISION (REFERENCE MFR. REPORT:1627487-2016-00638). COMPLICATIONS INVOLVING SCAR TISSUE AND A SEVERED LEAD OCCURRED DURING THE PROCEDURE AND AFTER MULTIPLE FAILED ATTEMPTS TO IMPLANT A NEW LEAD THE PROCEDURE WAS ABANDONED. THE PROCEDURE WAS PROLONGED BY AN HOUR BY THESE DIFFICULTIES. STIMULATION WAS EFFECTIVE PRIOR TO THE SURGICAL INTERVENTION. THE ENTIRE SCS SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 WHERE A NEW LEAD AND IPG WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801386 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 5688862

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other MODEL 1192(2), SCS ANCHOR| MODEL 3186 (2), SCS LEAD| MODEL 3771, SCS IPG