BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT VR

    MDR report key: 4288668 · Received December 1, 2014

    Report

    Report Number
    9614453-2014-02622
    Event Type
    Death
    Date Received
    December 1, 2014
    Date of Event
    November 3, 2014
    Report Date
    December 17, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. NO ISSUES WERE IDENTIFIED THAT REQUIRED FULL ANALYSIS.

    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 MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED ADVERSE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE BY THEIR SPOUSE. EMERGENCY MEDICAL SERVICES WERE CALLED. A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AT THE TIME OF THE EVENT DUE TO SHORT INTERVAL COUNTS AND NON-SUSTAINED HIGH RATE EPISODES. IT WAS NOTED THAT R WAVES WERE POOR. LEAD IMPEDANCES WERE STABLE. THERE WAS NO SIGN OF OVERSENSING. THE PATIENT DIED. CAUSE OF DEATH WAS UNKNOWN. A REMOTE TRANSMISSION WAS PERFORMED AT THE TIME OF THE EVENT AND THE PHYSICIAN FELT THERE WAS UNDERSENSING OF VENTRICULAR FIBRILLATION (VF). TECHNICAL REVIEW OF THE EPISODES REVEALED THE RHYTHM WAS CONSISTENT WITH AN AGONAL RHYTHM. TECHNICAL SERVICES DISCUSSED THAT INTERMITTENT UNDERSENSING CAN OCCUR DURING AN AGONAL RHYTHM. THE CALLER INQUIRED IF THE VF WOULD HAVE BEEN DETECTED HAD THE LIA NOT BEEN TRIGGERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775752 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 6947M62 LEAD