BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1791425 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03098
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    February 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DATA SHOWED 1 FAST VENTRICULAR TACHYCARDIA (FVT) AND 41 ASYSTOLE EPISODES POST IMPLANT. TECHNICAL SERVICES REVIEWED THE FAXED EPISODES AND THE FVT AND ASYSTOLE EPISODES LOOKED LIKE ARTIFACT. THE CALLER MEASURED THE R WAVES REAL TIME AT 0.2 MV AND CHANGED THE SENSITIVITY TO 0.025 MV. THESE FALSE EPISODES OCCURRED WITH THE SHIPPED SETTING VALUES. THE DEVICE WAS LATER REMOVED AND REPLACED WITH AN ICD. 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 83 YR Required Intervention