BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 2130412 · Received June 13, 2011

    Report

    Report Number
    1627487-2011-01645
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    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 PTS 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 MANUFACTURER REPORT: 1627487-2011-01637 AND 1627487-2011-01644.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH ANCHOR SPINAL CORD STIMULATION LEAD ACCESSORY GZB ST. JUDE MEDICAL - NEUROMODULATION 1194 3058606

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention