BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA VR

    MDR report key: 3993736 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14582
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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

    THE DEVICE WAS NOT RETURNED HOWEVER, ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) OVERSENSING. IT WAS NOTED THAT THE OVESENSING WAS DUE TO LEAD IMPEDANCE MEASUREMENT. ANALYSIS INFORMATION -- (B)(4) 2014 17:49:41 CST PLI# 10 PRODUCT ID# D204VRM. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) OVERSENSING.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO SHORT INTERVAL COUNTS (SIC) AND EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). EVALUATION OF STORED DEVICE DATA NOTED APPARENT T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. FURTHER ANALYSIS OF THE DATA REVEALED THAT THE LIKELY CAUSE OF THE APPARENT TWOS WAS DUE TO AN ISSUE THAT CAN OCCUR DURING RV LEAD IMPEDANCE MEASUREMENT BY THE DEVICE. THE PATIENT WAS LATER SEEN BY THEIR PHYSICIAN WHERE THERE WERE NO ADVERSE EVENTS NOTED AND NO REPROGRAMMING OF THE DEVICE PERFORMED. THE DEVICE 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
    472402 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR 7122Q58 COMPETITOR LEAD