BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL PLUS

    MDR report key: 1864619 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05154
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    MXC
    PMA / PMN Number
    K994331
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) BATTERY DEPLETION-NORMAL. THE DEVICE MET THE EXPECTED LONGEVITY OF 12 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NO OUTPUT. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL PLUS IMPLANTABLE LOOP RECORDER MXC MEDTRONIC MED REL, INC. 9526 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention