BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 1925637 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06335
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 25, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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. EVALUATION SUMMARY: (B)(4) THE CARDIAC MONITOR WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    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) THE CARDIAC MONITOR WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECENTLY-IMPLANTED IMPLANTABLE LOOP RECORDER DEVICE HAD RECORDED MORE THAN 400 ASYSTOLE EPISODES, AND THE CLINICIAN SUSPECTED THIS MAY HAVE BEEN DUE TO UNDERSENSING. THE DEVICE REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECENTLY-IMPLANTED IMPLANTABLE LOOP RECORDER DEVICE HAD RECORDED MORE THAN 400 ASYSTOLE EPISODES, AND THE CLINICIAN SUSPECTED THIS MAY HAVE BEEN DUE TO UNDERSENSING. IT WAS LATER REPORTED THAT THE IMPLANTABLE LOOP RECORDER DEVICE WAS EXPLANTED AND NOT REPLACED. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECENTLY-IMPLANTED IMPLANTABLE LOOP RECORDER DEVICE HAD RECORDED MORE THAN 400 ASYSTOLE EPISODES, AND THE CLINICIAN SUSPECTED THIS MAY HAVE BEEN DUE TO UNDERSENSING. THE DEVICE REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE IMPLANTABLE LOOP RECORDER DEVICE WAS EXPLANTED AND IT IS UNKNOWN WHETHER THE PATIENT WAS RE-IMPLANTED WITH ANOTHER LOOP RECORDER DEVICE OR IF THE PATIENT RECEIVED A DEVICE AND LEAD SYSTEM. ADDITIONAL INFORMATION RECEIVED WILL BE ADDED TO THE EVENT AND SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R