BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY DR

    MDR report key: 1842750 · Received September 23, 2010

    Report

    Report Number
    2182863-2010-00088
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6)2010 A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4). SINCE THE DEVICE REMAINS IMPLANTED, THE PROGRAMMER FILES WERE REVIEWED. THE FILES CONFIRMED THE REPORTED BEHAVIOR. THE MOST PROBABLE HYPOTHESIS IS THAT THE ELECTRICAL DISCHAGE MIGHT HAVE INDUCED A TRANSIENT ALTERATION IN THE FUNCTIONING OF SOME OF THE ELECTRONIC COMPONENTS. THE OBSERVED EVENT IS A WELL KNOWN ADVERSE EVENT THAT MAY OCCUR ON MEDICAL DEVICE WHEN IT IS SUBMITTED TO AN ELECTRICAL CURRENT FROM AN EXTERNAL SOURCE, AS MENTIONED IN THE LABELING. THE MANUFACTURER HAS RECOMMENDED A FOLLOW-UP TO BE SCHEDULED SHORTLY TO CONFIRM PROPER DEVICE BEHAVIOR. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AFTER IMPLANTATION, THE PATIENT WAS CARDIOVERTED FOR ATRIAL FIBRILLATION. FOLLOWING CARDIOVERSION, NO ATRIAL OR VENTRICULAR SENSING WAS OBSERVED. IN ADDITION, BOTH THE ATRIAL AND VENTRICULAR EGM'S WERE FLAT. HOWEVER, AFTER SOME TIME THE SENSING AND EGM RESUMED AND THE DEVICE APPEARS TO BE FUNCTIONING NORMAL DURING TESTING. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AFTER IMPLANTATION, THE PATIENT WAS CARDIOVERTED FOR ATRIAL FIBRILLATION. FOLLOWING CARDIOVERSION, NO ATRIAL OR VENTRICULAR SENSING WAS OBSERVED. IN ADDITION, BOTH THE ATRIAL AND VENTRICULAR EGM'S WERE FLAT. HOWEVER, AFTER SOME TIME THE SENSING AND EGM RESUMED, AND THE DEVICE APPEARS TO BE FUNCTIONING NORMAL DURING TESTING. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DR CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY DR

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR