BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 6008498 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06164
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    June 10, 2016
    Report Date
    July 14, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE ACTUAL LONGEVITY WAS LESS THAN 80% OF THE 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) COULD NOT BE INTERROGATED. THE ICM WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654574 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR