BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS SINGLE EXTENSION

    MDR report key: 3193592 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10213
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. 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 4 OF 4. REF MFR REPORTS: 1627487-2013-10210, 1627487-2013-10211 AND 1627487-2013-10212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288396 DBS SINGLE EXTENSION DBS LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 6346 3554421

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other