BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2953328 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01954
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WAS AN ALERT FOR LOW BATTERY VOLTAGE - RRT (RECOMMENDED REPLACEMENT TIME). CONCOMITANT PRODUCTS: 4196 IMPLANTABLE PACING LEAD, (B)(6) 2010; 5076 IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS REVEALED THAT THE DEVICE MET 80% OF THE EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A SHORT LONGEVITY IN TWO YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONSHAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56894 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 00087 YR Hospitalization| R 6947 IMPLANTABLE DEFIB LEAD