BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1792401 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03236
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UNCHECKED EXPLANTED FOR DEVICE 1. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PRIMARY ANALYSIS FINDING: SENSING (OTHER) WAS NOTED. THE LIFETIME FVT EPISODE COUNTER WAS AT 2469, THE LIFETIME ASYSTOLE EPISODE COUNTER WAS AT 57, AND THE LIFETIME TIME IN NOISE COUNTER WAS AT 70765086.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THE PATIENT EXPERIENCED A SYMPTOMATIC EPISODE: LIGHTHEADEDNESS BUT DID NOT ACTIVATE PATIENT ASSISTANT. THEREFORE, NO EPISODE WERE RECORDED ON THE DEVICE AT THE TIME OF THE EVENT. HOWEVER, SEVERAL NOISE EPISODES WERE SUBSEQUENTLY RECORDED AS FAST VENTRICULAR TACHYARRHYTHMIA OR FIBRILLATION (FVT), AND THERE WERE TWO ASYSTOLE EPISODES RECORDINGS DUE TO UNDERSENSING. CONSEQUENTLY, THE FOLLOWING ACTIONS WERE RECOMMENDED: REPROGRAM FVT INTERVAL FROM 300 TO 260 MILLISECONDS AND FVT DURATION FROM 9/12 TO 30/40. ADDITIONALLY, SENSITIVITY PROGRAM TO 0.025MV DUE TO UNDERSENSING EPISODES. NO 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 85 YR Required Intervention