BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 9084566 · Received September 18, 2019

    Report

    Report Number
    3004209178-2019-17916
    Event Type
    Death
    Date Received
    September 18, 2019
    Date of Event
    April 14, 2018
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169708624
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS PROVIDED AS 128, WITHOUT A UNIT OF MEASURE. 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. FOLLOW-UP WAS ATTEMPTED TO OBTAIN THE RELEVANT INFORMATION; HOWEVER, A CAUSE OF DEATH COULD NOT BE IDENTIFIED. 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
    877304 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01 00643169708624

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death 5076-52 LEAD, 5076-45 LEAD