BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3861749 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01420
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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. (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 INDICATED THERE WAS A PR LOGIC DETECTION. THE ANALYST NOTED THAT THE PR LOGIC WITHHELD FOR AT/AF EPISODES FOR OVER 2 HOURS INAPPROPRIATELY. THE AT/AF EVIDENCE COUNTER EVENTUALLY WAS LOST AND DETECTION OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL SYNCOPAL AND RECEIVED A SHOCK FROM THE DEVICE AT THE HOSPITAL. IT WAS NOTED THAT THE PATIENT HAD BEEN IN VENTRICULAR TACHYCARDIA (VT) TWO HOURS BEFORE THE DEVICE DELIVERED A SHOCK. IT WAS FURTHER DETERMINED THAT THE PR LOGIC HAD INCORRECTLY CLASSIFIED THE RHYTHM AS JUST ATRIAL FIBRILLATION (AF) WHEN IT SHOULD HAVE BEEN A DUAL TACHYCARDIA, THUS WITHHOLDING THERAPY. THE DEVICE WAS REPROGRAMMED AND REMAINS 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
    341716 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R