BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3161499 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-04714
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-04713. IT WAS REPORTED, THE PT WAS EXPERIENCING AUTO-REDUCING WHEN USING THE STIMULATION. F/U IDENTIFIED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248851 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3757632

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: