BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4113022 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-21615
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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: 1627487-2014-21616. REFERENCE MFR REPORT: 1627487-2014-21617. IT WAS REPORTED THE PT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS INDICATED INVALID IMPEDANCE VALUES. REPROGRAMMING WAS UNSUCCESSFUL AS THE ISSUE RECURRED. X-RAYS WERE INCONCLUSIVE. SURGICAL INTERVENTION WILL BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575270 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3186 3590596

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other SCS ANCHOR, MODEL 1192 (3)| IMPLANT DATE:| SCS EXTENSION, MODEL 3341| SCS IPG, MODEL 3716| IMPLANT DATE:| IMPLANT DATE: