BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA VR

    MDR report key: 3152416 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09043
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED RIGHT VENTRICULAR (RV) OVER SENSING. THERE WERE THREE LEAD FAILURE PREDICTORS (LFP) HIGH RATE NON-SUSTAINED EPISODES LESS THAN OR EQUAL TO 215 MS AVERAGE VENTRICULAR CYCLE BETWEEN (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SUBTHRESHOLD LEAD IMPEDANCE MEASUREMENT ON THE DEFIBRILLATOR, THERE WAS NOISE AND OVER SENSING SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. THIS PHENOMENON HAS BEEN NOTED IN SIMILAR SITUATIONS BEFORE. THE DEVICE IS STILL 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
    252683 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 6945 IMPLANTABLE TACHY LEAD