BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2952407 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00593
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON 2012 (B)(6) AND 2012 (B)(6). THE WEEKLY PACE LEAD TREND DATA SHOWED AN INCREASE FOR MINIMUM AND MAXIMUM RIGHT VENTRICULAR (RV) LEAD PACING OF 855 TO 2717 OHMS PEAK BETWEEN 2012 (B)(6) AND 2012 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED THRESHOLD AND HIGH IMPEDANCE. THE LEAD WAS CAPPED 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
    56573 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R