BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850378 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-05397
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 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 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: 1627487-2014-05398. IT WAS REPORTED THE PATIENT EXPERIENCED A HEADACHE AFTER RECEIVING A REPLACEMENT SCS SYSTEM. NO SIGNS OF A DURAL TEAR OR CEREBROSPINAL FLUID LEAKAGE WERE FOUND. THE REPLACEMENT PROCEDURE IS RELATED TO MFR REPORT: 1627487-2014-01130 AND 1627487-2014-01131. FOLLOW-UP REVEALED THE HEADACHE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319859 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4432392

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS ANCHORS: MODEL 1192 (X2)| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT: