BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2871464 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-12724
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2012-12725. THE PATIENT REPORTED NOT RECEIVING ADEQUATE STIMULATION COVERAGE. REPORTEDLY, THE PATIENT WANTS A DIFFERENT TYPE OF LEAD IMPLANTED. NOT THE PATIENT HAS TWO OCTRODE LEADS FROM DIFFERENT LOT NUMBERS IMPLANTED. BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2847760

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE: