BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE-SPACED QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1924714 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03469
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2009
    Report Date
    November 9, 2009
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 1627487-2010-03468 AND 1627487-2010-03470.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE-SPACED QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3166 175821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention