BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2952702 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00686
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS NOTED WITH 12 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(6) 2012. INTERFERENCE/NOISE WAS NOTED WITH A VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 13462 COUNTS, IN 60.68 DAYS, BETWEEN (B)(6) 2012. A LEAD INTEGRITY ALERT TRIGGERED WITH ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. HIGH RESISTANCE/IMPEDANCE WAS NOTED WITH TWO PATIENT ALERTS FOR OUT OF RANGE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACE BIPOLAR EQUAL TO 684 TO 4047 OHMS PEAK BETWEEN (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER THE PATIENT ALERT TRIGGERED. A DEVICE INTERROGATION SHOWED OVERSENSING AND HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. 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
    56292 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

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