BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2965022 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00398
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 17, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE WAS UNABLE TO CONFIRM AN ISSUE.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTABLE LOOP RECORDER (ILR) WAS UNABLE TO BE INTERROGATED THEREFORE WAS NOT IMPLANTED. THE ILR AND THE PATIENT ACTIVATOR WERE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTABLE LOOP RECORDER (ILR) WAS UNABLE TO BE INTERROGATED THEREFORE WAS NOT IMPLANTED. THE ILR AND THE PATIENT ACTIVATOR WERE RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM AN ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67036 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND 9528

    Patients

    Seq Age Sex Outcome Treatment
    1