BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3231448 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-11016
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    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

    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

    ON (B)(6) 2013, THE PT UNDERWENT SURGICAL INTERVENTION (REFERENCE MFR REPORT #: 1627487-2013-03551 AND 1627487-2013-03980). DURING THE PROCEDURE, THE DOCTOR ATTEMPTED TO IMPLANT TWO REPLACEMENT LEADS (FROM THE SAME LOT) BUT WAS UNSUCCESSFUL DUE TO SCAR TISSUE BEING PRESENT. IN THE ATTEMPT TO PLACE BOTH LEADS, THE PT EXPERIENCED A CEREBROSPINAL FLUID LEAK. AS A RESULT, THE PROCEDURE WAS ABANDONED. THE PT EXPERIENCED A HEADACHE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324718 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3929354

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention