BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3863257 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01333
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), HOWEVER PREMATURE BATTERY DEPLETION IS SUSPECTED DUE TO THE BATTERY DEPLETING VERY SUDDENLY. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341097 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R