BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2954332 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02395
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    March 22, 2013
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS CONTINUED: 694765 IMPLANTABLE TACHY LEAD: (B)(6) 2009. 419488 IMPLANTABLE PACING LEAD: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL PERFORMANCE ISSUE WITH THE DEVICE AS ITS LONGEVITY WAS LESS THAN FOUR YEARS WHEN IT REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED 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
    58324 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 00073 YR Hospitalization| R 507652 IMPLANTABLE PACING LEAD