BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2952775 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00719
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS RECEIVED AND ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS THE WEEKLY PACE IMPEDANCE TREND DATA SHOWS A GRADUAL INCREASE FROM MINIMUM AND MAXIMUM VENTRICULAR PACE IMPEDANCE FROM 848 TO 1584 OHMS PEAK BETWEEN (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASING AND HIGH IMPEDANCE WHICH TRIGGERED AN ALERT. IT WAS ALSO NOTED THAT THE LEAD WAS SUSPECTED TO BE FRACTURED PER X-RAY. THE LEAD WAS CAPPED AND REPLACED; HOWEVER, THE HIGH IMPEDANCE CONTINUED WHEN THE NEW LEAD WAS CONNECTED TO THE EXISTING DEVICE. THE DEVICE AND LEAD WERE DISCONNECTED AND CONNECTED MULTIPLE TIMES BUT THE IMPEDANCE REMAINED HIGH. THE DEVICE WAS EXPLANTED AND REPLACED, AND NORMAL IMPEDANCE WAS OBTAINED. THE NEW LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASING AND HIGH IMPEDANCE WHICH TRIGGERED AN ALERT. IT WAS ALSO NOTED THAT THE LEAD WAS SUSPECTED TO BE FRACTURED PER X-RAY. THE LEAD WAS CAPPED AND REPLACED; HOWEVER, THE HIGH IMPEDANCE CONTINUED WHEN THE NEW LEAD WAS CONNECTED TO THE EXISTING DEVICE. THE DEVICE AND LEAD WERE DISCONNECTED AND CONNECTED MULTIPLE TIMES BUT THE IMPEDANCE REMAINED HIGH. THE DEVICE WAS EXPLANTED AND REPLACED, AND NORMAL IMPEDANCE WAS OBTAINED. THE NEW LEAD AND DEVICE 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
    56025 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD