BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2142111 · Received May 25, 2011

    Report

    Report Number
    1627487-2011-02649
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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) RECEIVED AN SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON 2011 (B)(6). IT WAS REPORTED THE LEAD WAS ATTEMPTED BUT NOT USED DUE TO UNACCEPTABLE IMPEDANCES. THE LEAD WAS REMOVED FROM THE PT'S BODY AND THE SURGERY WAS ABORTED. THE PT WILL BE IMPLANTED AT A LATER DATE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3108615

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention