BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD, 30CM LENGTH

    MDR report key: 2150802 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-00851
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 RECEIVED AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2011. IT WAS REPORTED THAT HE IS WITHOUT STIMULATION. HE ALSO ALLEGES FEELING A SHARP PAIN BELOW THE IPG ON THE SPINAL REGION. THE PT HAS ADMITTEDLY FALLEN SINCE RECEIVING HIS SCS SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW PROGRAMMER WAS SHIPPED TO THE PT. IN ADDITION, A REPROGRAMMING SESSION WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 30CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3250316

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANTED: