BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 60 CM

    MDR report key: 2153139 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-00867
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    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

    EVAL: RESULTS: TWO LEADS OF THIS MODEL WERE RECEIVED. BOTH DEVICES WERE KINKED WITH ALL CONDUCTORS BROKEN. THE STIMULATION AND TERMINAL END OF THE DEVICES WERE NORMAL. DUE TO THE RETURNED CONDITION OF THE LEADS, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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 2 OF 4. REFERENCE MFR REPORT #S 1627487-2011-00866, 1627487-2011-00868 AND 1627487-2011-00869. THE PT RECEIVED AN SCS SYSTEM FOR LOW BACK AND RIGHT UPPER BUTTOCK PAIN INCLUDING AN IPG, THREE PERCUTANEOUS LEADS AND A LEAD EXTENSION ON (B)(6) 2008. IT WAS REPORTED ALTHOUGH THE PT FELT STIMULATION WHERE NEEDED, HIS SCS SYSTEM WAS EXPLANTED BECAUSE IT FAILED TO PROVIDE EFFECTIVE PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD, 3/4MM, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 173192

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention