BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA VR

    MDR report key: 3120852 · Received May 20, 2013

    Report

    Report Number
    9614453-2013-01055
    Event Type
    Death
    Date Received
    May 20, 2013
    Report Date
    August 17, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A LEAD INTEGRITY ALERT ON (B)(4) 2013 DUE TO MEETING THE CONDITIONS OF VENTRICULAR OVERSENSING AND NON-SUSTAINED TACHYCARDIA. EIGHT VENTRICULAR FIBRILLATION AND FIVE LEFT VENTRICULAR PACED EPISODES WERE NOTED LESS THAN 220 MILLISECONDS RECORDED ON (B)(4) 2013. IT WAS ALSO NOTED THAT 181 OF THE 272 LIFETIME VENTRICULAR SENSING INTEGRITY COUNTS ARE RECORDED BEGINNING (B)(4) 2012. PRODUCT ID: 6944-65, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. NO ANOMALIES WERE INDICATED ON THE DEVICE MEMORY. NOTED SHORT INTERVAL COUNTS AND LEAD INTEGRITY ALERT (LIA) THAT WAS TRIGGERED WAS DUE TO THE APPROPRIATELY SENSED VENTRICULAR FIBRILLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED DUE TO CLINICAL CONDITIONS WITH NO DEVICE OR LEAD ISSUE RELATED TO THE REPORTED DEATH. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222038 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Death