BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 3992094 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14916
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BELIEVES THE IMPLANTABLE CARDIAC MONITOR (ICM) DID NOT WORK AND IT RETURNED NO USEABLE INFORMATION WITH ONLY STATIC AND INTERFERENCE. THE PATIENT BELIEVES THE BATTERY HAS DEPLETED. A FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROVIDER YIELDED NO INFORMATION ON THE STATUS OF THE DEVICE OR THE CONDITION OF THE PATIENT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471205 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR