BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2790092 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05494
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FEELS THE ATRIAL ARRHYTHMIA ALGORITHMS MAY HAVE CONTRIBUTED TO HEART FAILURE. THESE ALGORITHMS WERE PROGRAMMED OFF AFTER THE MODESWICH EPISODE WAS THOUGHT TO BE LONGER THAN THE ARRHYTHMIA LASTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 5076 X 2 IMPLANTABLE PACING LEADS