BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2953011 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00867
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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. ANALYSIS REVEALED THAT THERE WAS HIGH OUT OF RANGE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ONE PATIENT ALERT FOR RV PACE LEAD Z GREATER THAN 2000 OHMS ON (B)(6) 2012 03:00:07. THE WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MIN AND MAX VENTRICULAR PACE EQUALING 563 TO 1864 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD'S IMPEDANCE REMAINS HIGH FOR TIP TO RING AND FOR TIP TO RV (RIGHT VENTRICULAR) COIL CONFIGURATIONS. THE LEAD WAS 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 ALERT WAS TRIGGERED FOR HIGH PACE/SENSE IMPEDANCE. IT WAS NOTED THAT THERE HAS BEEN A LINEAR RISE IN IMPEDANCE. THE LEAD REMAINS 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
    56677 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB