BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1881348 · Received October 7, 2010

    Report

    Report Number
    1627487-2010-02996
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 1 OF 3 (SEE MFR REPORT # 1627487-2010-02997 AND 1627487-2010-02998 FOR DEVICES 2 AND 3). THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2009 WHICH CONSISTED OF AN IPG AND FOUR PERCUTANEOUS LEADS FOR HEADACHES (OFF-LABEL INDICATION). ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. IN AN EFFORT TO RECAPTURE EFFECTIVE THERAPY, REPROGRAMMING WAS ATTEMPTED BUT PROVED UNSUCCESSFUL. A DIAGNOSTIC TEST WAS CONDUCTED AND REVEALED INVALID IMPEDANCE READINGS FOR EIGHT LEAD CONTACTS. THE PHYSICIAN WILL REPLACE THE AFFECTED LEADS AT A LATER DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINCAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3166 2858060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention