BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 3153677 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01155
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K103764
    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ANALYSIS REVEALED A DATA MISMATCH; PARITY ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIAGNOSTIC INFORMATION COULD NOT BE OPENED AND THE DISPLAY SHOWED INVALID DATA. THE PATIENT DECLINED A REPLACEMENT DEVICE AND A CLEAR DATA WAS PERFORMED. TWO TESTS OF SYMPTOMATIC RECORDINGS WERE THEN SUCCESSFULLY INTERROGATED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254399 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention