BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 1910917 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03375
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THE LEAD WAS RETURNED WITH THE OUTER TUBING DAMAGED BY POSSIBLE ELECTRO-CAUTERY DEVICE. TWO WIRES IN THE LEAD BODY WERE BROKEN ABOUT 4.5 CM FROM THE INSERTION HANDLE. THERE IS DARK DISCOLORATION INSIDE THE LEAD TUBING AS WELL. CONTINUITY TESTING PASSED FOR 2 OF THE LEAD CHANNELS. THE LOT NUMBER OF THE LEAD WAS NOT PROVIDED. 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 2 OF 2. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03374. THE PATIENT RECEIVED HIS SCS SYSTEM INCLUDING AN IPG AND LEAD(S) ON (B)(6) 2009. HE RECEIVED A SECOND SYSTEM INCLUDING A DIFFERENT MODEL IPG ON A LATER DATE. IT WAS REPORTED THAT THIS IPG WAS EXPLANTED ON (B)(6) 2010 FOR SUSPECTED END-OF-LIFE FOR THE IPG BATTERY. IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE, THE PHYSICIAN FOUND ONE OF THE LEADS APPEARED FRACTURED AND REPLACED IT AS WELL. BECAUSE THE PATIENT PARAMETERS WERE NOT AVAILABLE LONGEVITY CALCULATIONS COULD NOT BE PERFORMED TO CONFIRM NORMAL END-OF-LIFE FOR THE IPG BATTERY. THE IPG WAS REPLACED WITH A DIFFERENT MODEL IPG. THE EXPLANTED IPG AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND NO ADDITIONAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention