BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6142654 · Received December 2, 2016

    Report

    Report Number
    1627487-2016-06216
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    January 30, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 2 OF 2. REFERENCE MFR.1627487-2016-06177. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2017. REPORTEDLY, THE IPG WAS EXPLANTED AND REPLACED DURING THE PROCEDURE (REFERENCE MFR. REPORT#1627487-2016-05938). THE LEADS WERE TESTED PRIOR TO THE REVISION AND EFFECTIVE THERAPY WAS CONFIRMED. HENCE, THE ISSUE IS RESOLVED.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT#1627487-2016-06177. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER A PREVIOUS FALL. REPORTEDLY, DIAGNOSTIC TESTING WAS PERFORMED YIELDING LOW IMPEDANCE MEASUREMENTS ON MULTIPLE LEAD CONTACTS. IN TURN, X-RAYS WERE ORDERED HOWEVER LEAD MIGRATION WAS NOT CONFIRMED. FOLLOW-UP IDENTIFIED THE PHYSICIAN OPTED FOR SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793013 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3904347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192(2), SCS ANCHOR| MODEL 3688, SCS IPG