BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2203582 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04342
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 8, 2011
    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
    MA, 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) THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIAC MONITOR IS UNDERSENSING THE VENTRICULAR RHYTHM. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EPISODE WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE RECORDED TWO FALSE FAST VENTRICULAR TACHYCARDIA EPISODES AND ONE FALSE ASYSTOLE THAT APPEAR TO BE FROM NOISE. THE R WAVES WERE DIMINISHED AND WERE UNDERSENSED. NO INTERVENTION WAS TAKEN AND THE DEVICE REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIAC MONITOR IS UNDERSENSING THE VENTRICULAR RHYTHM. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EPISODE WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE RECORDED TWO FALSE FAST VENTRICULAR TACHYCARDIA EPISODES AND ONE FALSE ASYSTOLE THAT APPEAR TO BE FROM NOISE. THE R WAVES WERE DIMINISHED AND WERE UNDERSENSED. NO INTERVENTION WAS TAKEN AND THE DEVICE REMAINS IN USE. IT WAS LATER REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIAC MONITOR IS UNDERSENSING THE VENTRICULAR RHYTHM. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EPISODE WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 66 YR Hospitalization| O| R