BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 3160379 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10094
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED OVERSENSING OF ELECTRO-MAGNETIC INTERFERENCE (EMI)/NOISE AND AN ELECTRICAL RESET.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT WHAT NECESSITATED THE DEVICE REPOSITIONING PROCEDURE WAS DISCOLORATION AT THE IMPLANT SITE DUE TO FRICTION WHEN THE PATIENT WORE COMPRESSION CLOTHING DURING EXERCISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR RECORDED ASYSTOLE EPISODES THAT WERE CAUSED BY THE LOSS OF SIGNAL DUE TO NOISE. WHEN THE EPISODES WERE BEING REVIEWED, A DEVICE RESET WAS NOTED TO HAVE OCCURRED ABOUT THREE WEEKS PRIOR. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED; ANALYSIS REVEALED THE RESET WAS DUE TO CAUTERY THAT WAS USED DURING A DEVICE REPOSITIONING PROCEDURE. FOLLOW-UP IS IN PROGRESS TO DETERMINE WHAT NECESSITATED THE DEVICE REPOSITIONING PROCEDURE. THE DEVICE WAS INTERROGATED TO CLEAR THE RESET, IT WAS FUNCTIONING PROPERLY, AND 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
    261297 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R