BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2953664 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01291
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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 REVEAL THAT THERE WAS RV (RIGHT VENTRICULAR) OVERSENSING AS THERE WERE THREE LFP HIGH RATE ¿NS LESS THAN EQUAL TO 217 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012. THE RV LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AS THE DATA SHOWED ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. AND LASTLY THE DATA SHOWED THAT HERE WAS NON-PHYSIOLOGIC/SIC OVERSENSING AS THE VENTRICULAR SHORT INTERVAL COUNT (V-SIC) EQUALED 362 COUNTS IN 12.83 DAYS, BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS T-WAVE OVERSENSING AND HAD TRIGGERED THE LEAD INTEGRITY ALERT. 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
    55598 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB