BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2951661 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01577
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0112-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 : 4196 IMPLANTABLE PACING LEAD (B)(6) 2009; 4574 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO A RIGHT VENTRICULAR LEAD FRACTURE. NOISE WAS ALSO NOTED ON THE LEAD. THE LEAD WAS PARTIALLY EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE BATTERY PREMATURELY DEPLETED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56238 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 00054 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD