BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1921771 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05831
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED FOR ANALYSIS AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESULTS OF THE IMPLANTABLE MONITOR WERE DIFFICULT TO CORRELATE WITH SYMPTOMS DUE TO POSSIBLE "NOISE" ON STRIPS. IT WAS ALSO REPORTED THAT THE DEVICE WAS POSSIBLY OVERSENSING OR UNDERSENSING. DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R