BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1890011 · Received November 3, 2010

    Report

    Report Number
    2124215-2010-21217
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THIS LV LEAD WAS REVISED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. LV PACING PERCENTAGES WERE ALSO LOWER THAN EXPECTED, AND IT WAS SUSPECTED THAT THE LV LEAD MAY HAVE DISLODGED. LV SENSING WAS TEMPORARILY PROGRAMMED OFF UNTIL A REVISION PROCEDURE COULD BE PERFORMED.

    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 65 YR Other 4592| 0185| N119| 4136