BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1873949 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17921
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    November 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE IS EXPECTED TO BE SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED. IT IS UKNOWN WHETHER THE LEAD WILL BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED IF THE LEAD IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP, IT WAS NOTED THIS LEFT VENTRICULAR LEAD HAD DISLODGED. IT WAS REPORTED THE PATIENT HAD EXTREMELY TORTUOUS CORONARY SINUS ANATOMY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE LEAD HAD HIGH PACING THRESHOLD MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1