BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

    MDR report key: 8028493 · Received November 1, 2018

    Report

    Report Number
    1627487-2018-10726
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 7, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    05415067020680
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487-10/16/18-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRECTIVE/PREVENTIVE ACTION PLAN HAS BEEN INITIATED BY THE MANUFACTURER TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 1

    THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED (B)(6) 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRAIN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE RADIOGRAPH IS NORMAL; THEREFORE, THE MATERIAL SEGREGATION ISSUE DESCRIBED IN FSCA 1627487-10/16/18-001-R DID NOT AFFECT THIS LEAD. NO ADDITIONAL ACTION WITH THE PATIENT IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869863 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B DBS LEAD MHY ST. JUDE MEDICAL - NEUROMODULATION 6172 6197962 05415067020680

    Patients

    Seq Age Sex Outcome Treatment
    1