BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2201359 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03764
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 6, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND. THE DEVICE ATTEMPTS TO DELIVER ATRIAL ANTI-TACHYCARDIA PACING (ATP) ON THE VP IMMEDIATELY PRIOR TO THE 1660 MS V-V INTERVAL. IF THERE IS AN ATRIAL SENSE WITHIN THE 500 MS, THE DEVICE SYNCHRONIZES THE ATRIAL ATP TO THAT ATRIAL SENSE AND DELIVERS ATRIAL ATP. IF THERE IS NOT AN ATRIAL SENSE WITHIN THE 500 MS, THE DEVICE ABORTS THE ATRIAL ATP. AT THAT TIME THE DEVICE SWITCHES BACK TO THE OPERATING MODE AND STARTS A PACING CYCLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH PRESYNCOPAL SYMPTOMS. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 5076 (X2) IMPLANTABLE PACING LEAD