BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 3862129 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11063
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT THE PATIENT WAS "MISSING BEATS" THE LAST FEW WEEKS AND UNDERSTOOD THAT THE LOWER PACING RATE WAS PROGRAMMED TO 50 BEATS PER MINUTE (BPM), BUT THAT ONE DAY, THE HEART RATE WAS AT 34 BPM AND THEN AT 44 BPM. FOLLOW-UP WITH THE DEVICE CLINIC NOTED THE PATIENT HAD NOT CALLED WITH THESE CONCERNS AND HAD CANCELLED AN APPOINTMENT. A NEW APPOINTMENT IS SCHEDULED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341521 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR 6947-65 LEAD