BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3001461 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01263
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    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

    EVALUATION: RESULTS: THE COMPLAINT OF "CANNOT IMPLANT PRODUCT" COULD NOT BE CONFIRMED THROUGH PRODUCT TESTING ALONE; THEREFORE, NO CHECKLIST WAS INITIATED PER 56-0258. AS STATED IN THE EVENT DETAILS, THE DOCTOR COULD NOT ADVANCE THE LEAD DUE TO THE PATIENT'S ANATOMY AND THE PROCEDURE WAS ABORTED. THERE IS NO ALLEGED FAILURE TO MEET SPECIFICATION. THE PRODUCTS WERE RETURNED WITHOUT ANY VISIBLE ANOMALIES OR DAMAGE. WE DID NOT IDENTIFY ANY DEFECTS THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. 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

    THE PATIENT HAD TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PHYSICIAN ATTEMPTED TO IMPLANT TWO NEW OCTRODE LEADS DURING A REVISION SURGERY FOR LEAD MIGRATION. THE PHYSICIAN WAS UNABLE TO ADVANCE THEM TO THE NECESSARY PLACEMENT DUR TO SCAR TISSUE. THE LEADS WERE REMOVED AND THE PATIENT WILL BE REFERRED FOR A PADDLE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92932 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3889386

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention