BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4093642 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-24147
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    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 INFO 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 2. REFERENCE MFR. REPORT: 1627487-2014-24148. THE PT RECEIVE 2 MODEL 3186 LEADS (FROM THE SAME LOT) AS PART OF THE HIS SCS SYSTEM. IT WAS REPORTED THE PT EXPERIENCED INEFFECTIVE STIMULATION, SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541573 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3792159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other IMPLANT DATE: 01/01/2012| IMPLANT DATE: 01/01/2012| SCS ANCHOR, MODEL 1194(2)| SCS IPG, MODEL 3788