BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2160761 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-01720
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    IT WAS REPORTED THAT THE PT (B)(6) UNDERWENT A SCS TRIAL PROCEDURE. AFTER IMPLANTATION OF THE TRIAL LEAD, STIMULATION WAS TESTED AND THE AMPLITUDE ALLEGEDLY WOULD NOT INCREASE. DIAGNOSTIC TESTS REVEALED INVALID OR HIGH IMPEDANCE READINGS ON ALL LEAD CONTACTS. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD DURING THE TRIAL PROCEDURE. THE PT REPORTED EFFECTIVE STIMULATION WITH THE REPLACEMENT LEAD, AND NO FURTHER PT COMPLICATIONS WERE REPORTED.

    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 3179645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention