BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2964947 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01533
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AJ
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS : 5076 IMPLANTABLE PACING LEAD (B)(6) 2010; 4948 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND A LEAD INTEGRITY ALERT WAS TRIGGERED. THE LEAD WAS REPROGRAMMED AND APPROPRIATE SENSING WAS RESTORED. THE FOLLOWING DAY, AN ALERT WAS TRIGGERED AGAIN AND THE PACE/SENSE PORTION OF THE LEAD HAD A SUDDEN INCREASE IN IMPEDANCE TO MORE THAN 3000 OHMS. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED AND THE HIGH VOLTAGE PORTION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT A PATIENT CAME TO THE CLINIC WITH ACTIVATED LIA ALERT. VENTRICULAR OVERSENSING EPISODES AND A SUDDEN INCREASE OF RV LEAD IMPEDANCE (MORE THAN 3.000 OHMS) WERE OBSERVED DURING THE FU. THE RV LEAD WAS REPLACED AND THE EXISTING LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68153 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D294TRK IMPLANTABLE DEFIBRILLATOR