BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/6MM, 90 CM

    MDR report key: 2000768 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00205
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 3. PLEASE REFERENCE MFR REPORT # 1627487-2011-00206 AND 1627487-2011-00185. THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2007. SHE LATER RECEIVED TWO PERCUTANEOUS LEADS. ONE LEAD WAS PLACED ON (B)(6) 2008 AS PART OF A TRIAL PROCEDURE AND THE OTHER WAS IMPLANTED ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING ADEQUATE THERAPY RELIEF. DIAGNOSTIC TESTS ON THE PT'S LEFT LEAD REVEALED HIGH IMPEDANCE READINGS FOR TWO ELECTRODES. THE IMPEDANCE READINGS FOR THE RIGHT LEAD WERE WITHIN SPECIFICATIONS, BUT THE PT ALLEGED THAT SHE EXPERIENCED OVERSTIMULATION WHEN THE DEVICE WAS IN USE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE ONE OF THE PT'S LEADS AND HER IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD, 3/6MM, 90 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3159 113527

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention