BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2911433 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17107
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR ASSISTANCE IN PROGRAMMING THE LEAD OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT'S ANATOMY WAS VERY CHALLENGING AND IT TOOK SEVERAL HOURS TO INITIALLY IMPLANT THIS LV LEAD. DUE TO THE DIFFICULTY OF THAT PATIENT'S ANATOMY, THE PHYSICIAN HAS ELECTED TO MONITOR THE PATIENT AT THIS TIME. IT WAS CONFIRMED THAT THE LEAD WAS SUCCESSFULLY PROGRAMMED OFF, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17576 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR N161| 4469| N119| 4555| 0185| 4543| 4592| 4136