BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2053300 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04057
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT VENTRICULAR LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY POST IMPLANT AFTER SECURING THE LEADS, IT WAS NOTED THAT THIS LEFT VENTRICULAR LEAD HAD MOVED OR MICRO-DISLODGED. DUE TO THE SHAPE OF THE LEAD IT WAS SUSPECTED THAT THIS TYPE OF LEAD MAY SPRING OUT OF PLACE EASILY. THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.

    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 Other