BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1970210 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01163
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THIS LEAD HAS NOT BEEN REMOVED FROM SERVICE. THE PATIENT IS NOT DEPENDENT ON LV PACING. THE INVESTIGATION IS NOW CONSIDERED CLOSED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD HAD BEEN RECENTLY IMPLANTED AND THEN BECAME DISLODGED. THIS ISSUE WAS DETERMINED BY CHEST X-RAY. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)