BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2142106 · Received May 26, 2011

    Report

    Report Number
    1627487-2011-01565
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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

    THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION AND COULD NOT FEEL STIMULATION WHEN THE AMPLITUDE WAS INCREASED. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE MEASUREMENTS ON ALL LEAD CONTACTS. DURING REPROGRAMMING, IT WAS OBSERVED THAT STIMULATION COULD NOT BE ACHIEVED WITH LEAD CONTACTS 5-8. IT WAS REPORTED THAT EFFECTIVE STIMULATION COVERAGE WAS CAPTURED USING CONTACTS 1-4. NO FURTHER PATIENT 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 46634

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG, MODEL: 3716| IMPLANT:| IMPLANT:| SCS EXTENSION, MODEL: 3383