BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5131351 · Received October 7, 2015

    Report

    Report Number
    1627487-2015-21206
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 16, 2015
    Report Date
    October 9, 2020
    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
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2015-21207. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO AUTO-REDUCTION. DIAGNOSTIC TESTING INDICATED MULTIPLE INVALID LEAD IMPEDANCES. REPROGRAMMING WAS UNSUCCESSFUL IN ADDRESSING THE ISSUE. SURGICAL INTERVENTION IS PLANNED AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662895 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 4224606

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 1192(X2), SCS ANCHOR