BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2921672 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-10014
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMOMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 DURING THE PROCEDURE TO IMPLANT THE SCS SYSTEM, INVALID IMPEDANCES WERE IDENTIFIED ((B)(6)) INTRA-OPERATIVE TESTING CONFIRMED THE LEAD EXTENSION WAS THE SOURCE OF THE ISSUE. A NEW LEAD EXTENSION WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS EXTENDED APPROXIMATELY 20 MINUTES WITH NO ADVERSE EFFECTS NOTED. EFFECTIVE STIMULATION WAS ACHIEVED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13970 SINGLE EXTENSION SCS LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMOMODULATION 3386 3538814

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention