BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA PADDLE LEAD

    MDR report key: 2251528 · Received September 14, 2011

    Report

    Report Number
    1627487-2011-05140
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 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

    RESULTS: THE PRODUCT WAS RECEIVED COMPLETE. THE LEAD WAS OBSERVED TO BE SEVERELY KINKED WITH ALL WIRES BROKEN. MOST LIKELY STRESS WAS INDUCED WHILE THE DEVICE WAS IMPLANTED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE. 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

    THE PT RECEIVED HIS PADDLE LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S LEAD WAS EXPLANTED DUE TO THE LEAD BEING FRACTURED. THE LEAD WAS REPLACED WITH ANOTHER PADDLE LEAD. AN SJM REP REPORTED THAT THE PROGRAMMING VISIT WITH THE PT WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3228 3319725

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: