BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 3934841 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13017
    Event Type
    Death
    Date Received
    July 15, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER IMPLANT OF THE IMPLANTABLE PULSE GENERATOR THE PATIENT HAD CARDIAC ARREST AND DIED. IT WAS NOTED THAT THE DEVICE DID NOT SENSE THE VENTRICULAR FIBRILLATION AND A PREMATURE VENTRICULAR CONTRACTION WAS NOT SENSED. IT WAS ALSO NOTED THAT THE PACING SPIKE DID NOT CAPTURE PRIOR TO THE VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413450 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death 5076 LEADS X2