BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 2060282 · Received April 15, 2011

    Report

    Report Number
    6000144-2011-01352
    Event Type
    Injury
    Date Received
    April 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, ANALYZED, NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INFECTION, SO THE DIAGNOSTIC MONITOR WAS EXPLANTED. NO FURTHER 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 MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R