BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2953066 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00192
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 29, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED A RESISTANCE/IMPEDANCE INCREASE. WEEKLY PACE IMPEDANCE TREND DATA SHOWS AN INCREASE FOR MIN AND MAX RIGHT VENTRICULAR (RV) PACE OF 752 TO 3536 OHMS PEAK BETWEEN (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE INCREASED GRADUALLY OVER TIME ALONG WITH A SLIGHTLY INCREASED PACING THRESHOLD. THE PHYSICIAN SUSPECTED A LEAD ISSUE, HOWEVER THE LEAD WAS CHECKED WITH THE ANALYZER AND NORMAL IMPEDANCE AND THRESHOLD WAS FOUND. AFTER CLEANING THE DEVICE CONNECTORS THE PHYSICIAN RECONNECTED THE DEVICE AND THE IMPEDANCE WAS AGAIN HIGH. A CONNECTOR ISSUE WAS SUSPECTED SO THE DEVICE WAS EXPLANTED AND REPLACED. CONNECTING THE LEAD TO THE NEW DEVICE RESULTED IN AN ACCEPTABLE IMPEDANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56080 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R