BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

    MDR report key: 8007398 · Received October 25, 2018

    Report

    Report Number
    1627487-2018-10193
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 3, 2018
    Report Date
    December 5, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    05415067020697
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE, BATCH LOT NUMBER AND EXPIRATION DATE WERE REPORTED INCORRECTLY IN THE INITIAL REPORT. THE CORRECT INFORMATION IS ADDED TO THE REPORT. AS FOLLOWS: MANUFACTURING DATE DEC 7, 2017, EXPIRATION DATE: DEC 7, 2019, SERIAL NUMBER #(B)(4), BATCH LOT NUMBER #6212658.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT#1627487-2018-10188. IT WAS REPORTED THAT THE EXPERIENCED SPEECH IMPAIRMENT. PATIENT WENT TO THE EMERGENCY ROOM (ER). CT WAS NEGATIVE. REPORTEDLY, THE PATIENT IS HOSPITALIZED FOR FURTHER INVESTIGATIONS. CAUSE OF THE EVENT IS UNKNOWN AND PATIENT IS DOING BETTER. THE EVENT HAS BEEN RESOLVED. PATIENT IS A PART OF 'PROGRESS' CLINICAL STUDY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT#1627487-2018-10188.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846491 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B DBS LEAD MHY ST. JUDE MEDICAL - NEUROMODULATION 6173 6212658 05415067020697

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization