BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS TRIAL LEAD

    MDR report key: 2033523 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01301
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A (B)(4) TRIAL SYSTEM, INCLUDING TWO PERCUTANEOUS TRIAL LEADS, ON (B)(6) 2011. IT WAS REPORTED THAT POSTOPERATIVE DIAGNOSTIC TESTS EXHIBITED HIGH IMPEDANCE READINGS ON SEVERAL LEAD CONTACTS. THE PATIENT WAS ALLEGEDLY REPROGRAMMED AROUND THE LEAD CONTACTS WITH HIGH VALUES AND REPORTED EFFECTIVE STIMULATION. FOLLOW UP ON THE PATIENT FOUND THAT AFTER A COUPLE OF DAYS, SEVERAL LEAD CONTACTS REVEALED INVALID IMPEDANCES. IT WAS REPORTED THAT SIX CONTACTS WERE USED AND PROVIDED EFFECTIVE STIMULATION. THE PATIENT FINISHED THE TRIAL, AND THE LEADS WERE EXPLANTED. THE EXPLANT DATE IS CURRENTLY UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3086 3240770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention