BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2932336 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-10025
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY ACCESSING THE PATIENT'S EPIDURAL SPACE WHEN ATTEMPTING TO PLACE THE SCS LEAD ((B)(6)). AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO PLACE THE LEAD; HOWEVER, THE LEAD HAD BECOME DAMAGED IN THE PROCESS. THE PROCEDURE WAS COMPLETED USING A NEW LEAD. THE PROCEDURE WAS EXTENDED 75 MINUTES AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34843 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3143 3766710

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention