BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2041833 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-04924
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO MONTHS LATER, THE LEAD WAS REMOVED FROM SERVICE AND SUCCESSFULLY REPLACED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT STATED THAT HIS PHYSICIAN IS AWARE OF THE ISSUE. THE LEAD WAS SUBSEQUENTLY EXPLANTED. BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS AS THE LEAD WAS NOT RETURNED FOR TESTING. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THIS PATIENT THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND WAS EXHIBITING LOSS OF CAPTURE. THE PATIENT STATED THAT THE LEAD HAS BEEN PROGRAMMED OFF FOR NOW AND THE LEAD WILL BE REPOSITIONED IN MARCH. THE PATIENT STATED HE HAS BLOOD CLOTS AND BELIEVES THEY ARE DUE TO THE IMPLANT OF THIS LV LEAD.

    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 75 YR 0145| 1851| A155| 4054| N119| 4555