BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2865107 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17628
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE. THERE WERE PATIENT ALERTS FOR RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ON (B)(6) 2012. THE WEEKLY PACE LEAD TREND DATA SHOWED A GRADUAL INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACING OF 680 TO 6128 OHMS PEAK BETWEEN (B)(6) 2012.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING LEAD IMPEDANCE WAS HIGH AND THE PACING THRESHOLD WAS HIGH. 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
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L 7232CX IMPLANTABLE CARDIAC DEFIBRILLATOR