BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2952830 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00734
    Event Type
    Injury
    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
    GM
    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: PRODUCT PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS TWO PATIENT ALERTS FOR RV PACING LEAD IMPEDANCE GREATER THAN 3000 OHMS OCCURRED ON (B)(6) 2012 AND (B)(6) 2012. THE WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACING FROM 968 TO 16384 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS TWO PATIENT ALERTS FOR RV PACING LEAD IMPEDANCE GREATER THAN 3000 OHMS OCCURRED ON (B)(6) 2012. THE WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACING FROM 968 TO 16384 OHMS PEAK BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASED AND UNDEFINED IMPEDANCE. A LEAD REVISION WAS PLANNED. 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 INCREASED AND UNDEFINED IMPEDANCE. A LEAD REVISION WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56429 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD