BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 3155968 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-09540
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0113-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PRODUCT PERFORMANCE INFORMATION WAS ALSO RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT. THE WEELY BATTERY VOLTAGE TREND DATA SHOW MINUMUM BATTERY WAS 3.097 TO 3.037 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2013 IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME <(><<)>=2.6251 VOLT.

    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: 6944-58 IMPLANTABLE TACHY LEAD, (B)(6) 2009; 4574 IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV COIL AND SCV COIL IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH. THE DEVICE WAS ALSO NOTED TO HAVE DECREASED LONGEVITY. BOTH THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV COIL AND SCV COIL IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH. THE DEVICE WAS ALSO NOTED TO HAVE DECREASED LONGEVITY. BOTH THE LEAD AND DEVICE WERE 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
    257945 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R