BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2780369 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-06511
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 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 HAD TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PT WAS NOT RECEIVING ADEQUATE COVERAGE. ALLEGEDLY, BOTH LEADS HAD MIGRATED. THE LEADS WERE EXPLANTED AND REPLACED. THE EXPLANTED PRODUCT WAS DISCARDED BY THE SURGICAL FACILITY. COVERAGE WAS REGAINED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2787306

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788