BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3992687 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01963
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PRE-SYNCOPE AND A STRESS TEST WAS PRESCRIBED. ON THE TREADMILL, THE DEVICE SENSED AND PACED APPROPRIATELY, HOWEVER, ON CONCLUSION OF THE EXERCISE IT WAS NOTED THAT THE PATIENT'S DEVICE ALLOWED SLOW HEART RATES DOWN TO 40 BEATS PER MINUTE IN THE PRESENCE OF T-WAVE OVERSENSING (TWOS) ON DECELERATION. SENSITIVITY WAS ADJUSTED AND THE RIGHT VENTRICULAR (RV) LEAD POLARITY WAS CHANGED TO INTEGRATED BIPOLAR FOR DETECTION. TWOS WAS RESOLVED AND THE PATIENT WILL BE SEEN ON ROUTINE FOLLOW-UP IF SYMPTOMS RECUR. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470346 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6935M-62 LEAD