BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2122923 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00704
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VECTOR CHECK WITH THE DEVICE DURING THE IMPLANT ATTEMPT, THE R-WAVE AMPLITUDE BECAME SMALLER IN DIFFERENT POSITIONS. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC S.A. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other