BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2954697 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02479
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD: (B)(6) 2007. 6949 IMPLANTABLE TACHY LEAD: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY DUE TO HIGH LEFT VENTRICULAR ( LV) LEAD THRESHOLDS. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD HIGH THRESHOLD MEASUREMENTS. THE DEVICE WAS EXPLANTED AND REPLACED; THE LV AND ATRIAL LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58658 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD