BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 2921899 · Received January 15, 2013

    Report

    Report Number
    1627487-2013-05085
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 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

    ON (B)(6) 2012, THE PT UNDERWENT A TRIAL PROCEDURE. INVALID IMPEDANCE WAS FOUND AFTER THE LEAD WAS PLACED. THE DOCTOR MOVED THE LEAD AND TRIAL CABLES WERE CHANGED TO NO AVAIL. ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE AD RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23280 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3066 3773642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention