BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLIA MRI QUAD CRT-D SURESCAN

    MDR report key: 9245723 · Received October 28, 2019

    Report

    Report Number
    3004209178-2019-20545
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    August 27, 2018
    Report Date
    November 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169543386
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ODD RHYTHM APPEARED ON THE REMOTE TRANSMISSION, APPARENTLY DUE TO THE RIGHT ATRIAL (RA) LEAD NOT CAPTURING. RA PACING THRESHOLDS WERE LATER NOTED TO HAVE INCREASED AND WERE DESCRIBED AS HIGH. LEAD OUTPUT WAS SUBSEQUENTLY INCREASED. THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LATER EXHIBITED PREMATURE BATTERY DEPLETION DUE TO THE HIGH RA THRESHOLDS. THE CRT-D WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041866 AMPLIA MRI QUAD CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMB1QQ 00643169543386

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 6935M62 LEAD, 429888 LEAD, 407652 LEAD