BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2952207 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01682
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 29, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) UNDERSENSING INFORMATION. THE ANALYST COMMENTED, CLINICIAN MANUAL STATES: LOSS OF CONTACT BETWEEN THE DEVICE ELECTRODES AND POCKET OR MUSCLE TISSUE MAY BE INDICATED BY A SHARP DEFLECTION OF THE ECG SIGNAL FOLLOWED BY A GRADUAL RETURN TO BASELINE, A LACK OF OBSERVABLE CHANGES IN THE HEART RHYTHM AND RATE BEFORE AND AFTER AN ASYSTOLE EVENT, AND OBSERVABLE ¿MICRO-SIGNALS¿ OCCURRING AT A REGULAR INTERVAL OF APPROXIMATELY 160 MS (THE TELEMETRY FREQUENCY OF THE DEVICE). FALSE DETECTIONS OF ASYSTOLE TYPICALLY OCCUR WITHIN THE FIRST FEW WEEKS AFTER IMPLANT AND ARE USUALLY PREVENTED BY CREATING A TIGHT POCKET FOR THE DEVICE. THE ATTACHED EPISODE IS CONSISTENT WITH THE BEHAVIOR DESCRIBED ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED REVEAL IMPLANTABLE CARDIAC MONITOR WAS UNDERSENSING AND DETECTED SEVERAL EPISODES OF FALSE ASYSTOLE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56642 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR