BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2040353 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-02298
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE PT (B)(6) REC'D AN SCS SYSTEM, WHICH INCLUDED A PERCUTANEOUS LEAD. IT WAS REPORTED THE PT LOST STIMULATION. A DIAGNOSTIC TEST OF THE LEAD REVEALED HIGH IMPEDANCES ON FIVE OF THE EIGHT LEAD CONTACTS. THE PHYSICIAN INDICATED A REVISION WOULD BE PERFORMED; HOWEVER, NO SURGERY DATE HAS BEEN SET. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 174056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention