BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH LEAD ANCHOR

    MDR report key: 1980407 · Received February 3, 2011

    Report

    Report Number
    1627487-2011-00161
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 28, 2009
    Report Date
    January 6, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 3 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00159 AND 1627487-2011-00160. THE PT REC'D HIS SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND AN ANCHOR. IT WAS REPORTED THAT THE IMPLANT PROCEDURE TOOK OVER 8 HOURS TO COMPLETE AND RESULTED IN EXTREME PAIN FOR THE PT. IT IS ALSO ALLEGED THAT HIS SCS SYSTEM IS NOT PROVIDING ADEQUATE STIMULATION COVERAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE REQUIRED SURGICAL INTERVENTION TO RECTIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH LEAD ANCHOR SPINAL CORD STIMULATION ACCESSORY LGW ST JUDE MEDICAL - NEUROMODULATION DIV 1194 2863639

    Patients

    Seq Age Sex Outcome Treatment
    1