BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS SINGLE EXTENSION

    MDR report key: 4201969 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-25654
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR THE SALE IN THE US. 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

    DEVICE 2 OF 2. REF MFR REPORT# 1627487-2014-25653. IT WAS REPORTED THE PT (B)(6) LOST STIMULATION. LEAD DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE MEASUREMENTS. IN TURN, THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S EXTENSIONS WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663308 DBS SINGLE EXTENSION DBS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 6345 3736555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other