BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH LEAD ANCHOR

    MDR report key: 2033529 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-00409
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 3. REFERENCE MFR. REPORT #S 1627487-2011-00400 AND 1627487-2011-00410.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH LEAD ANCHOR SPINAL CORD STIMULATION ANCHOR GZB ST JUDE MEDICAL - NEUROMODULATION DIV. 1194 2928101

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention