BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2113723 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-02700
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    TX, 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

    DEVICE 1 OF 4: REFERENCE MFR REPORTS: 1627487-2011-02701, 1627487-2011-02702, AND 1627487-2011-02703. THE PT RECEIVED AN SCS SYSTEM, INCLUDING FOUR PERCUTANEOUS LEADS (OF TWO SEPARATE LOTS) AND TWO EXTENSIONS. IT WAS REPORTED THE LEADS AND EXTENSIONS WERE EXPLANTED AND REPLACED DUE TO MIGRATION. THE LEADS AND EXTENSIONS WERE DISCARDED BY THE FACILITY. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 2822544

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANTED: