BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 9098306 · Received September 20, 2019

    Report

    Report Number
    3008973940-2019-02603
    Event Type
    Death
    Date Received
    September 20, 2019
    Date of Event
    April 8, 2018
    Report Date
    September 20, 2019
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    UDI-DI
    00643169708686
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-45 LEAD, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED. THE CAUSE OF DEATH WAS PROVIDED AS: CARDIO PULMONARY ARREST AND CORONARY ARTERY DISEASE. ADDITIONAL INFORMATION RECEIVED NOTED THAT TWO MONTHS PRIOR TO THE PATIENT¿S DEATH A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED AND NOTED ENLARGEMENT OF THE LEFT THYROID WITH TRACHEAL DEVIATION AND A LEFT ADRENAL MASS. ALSO NOTED WERE MULTIPLE HYPODENSE LESIONS IN THE LIVER SUSPICIOUS FOR METASTASIS. THIS EVENT IS BEING CONSERVATIVELY REPORTED IN AN ABUNDANCE OF CAUTION IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EPISODE. THIS PATIENT WAS CONFIRMED TO BE PROGRAMMED TO A PACING MODE SUSCEPTIBLE TO THE DESCRIBED ADVISORY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892226 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDRL1 00643169708686

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death 4456 LEAD