BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 3051176 · Received April 10, 2013

    Report

    Report Number
    9614453-2013-00946
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WAS AN ALERT FOR HIGH RESISTANCE/IMPEDANCE. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCES ARE RECORDED ON (B)(6) 2012 (IMPLANT DATE) AND (B)(6) 2013. DEFIB ACTIVE CAN AND VENTRICULAR PACE IMPEDANCES ARE HIGH AT IMPLANT (254 AND 4047 OHM RESPECTIVELY); DEFIB ACTIVE CAN AND SUPERIOR VENA CAVA (SVC) IMPEDANCES RISE AGAIN THE WEEK ENDING (B)(6) 2013. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) FOR HIGH RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) IMPEDANCE IMMEDIATELY AFTER IMPLANT. THE IMPEDANCE VALUES WERE WITHIN NORMAL RANGE THE NEXT DAY USING ANOTHER PROGRAMMER, HOWEVER ANOTHER ALERT TRIGGERED TWO MONTHS LATER. THE DEVICE AND LEAD 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
    152853 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 6947 IMPLANTABLE TACHY LEAD