BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE TRIAL LEAD, 60CM LENGTH

    MDR report key: 2092678 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-00640
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    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 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 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00641. THE PT WAS SCHEDULED TO HAVE TWO PERCUTANEOUS LEADS PLACED IN THE CERVICAL EPIDURAL SPACE FOR FINGER PAIN IN THE LEFT HAND AS WELL AS TWO PERCUTANEOUS LEADS IN THE UPPER THORACIC EPIDURAL SPACE FOR BILATERAL BACK AND LEG PAIN. DURING THE IMPLANT PROCEDURE, THE PT COMPLAINED OF PAINFUL DYSTHESIAS ONCE THE LEFT LEAD WAS INTRODUCED INTO THE CERVICAL EPIDURAL SPACE. THE REPORTED PAIN DID NOT DECREASE; AS SUCH, THE PHYSICIAN ELECTED TO ABORT THE CERVICAL LEAD PLACEMENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO PERCUTANEOUS LEADS AS INTENDED IN THE UPPER EPIDURAL SPACE. THE PT UNDERWENT CT SCANS FOLLOWING THE PROCEDURE; HOWEVER, ALL FINDINGS WERE NEGATIVE. THE PAIN EXPERIENCED BY THE PT REPORTEDLY SUBSIDED WITHIN TWO DAYS OF THE SURGERY. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE TRIAL LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3046 3143316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention