BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3043143 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01791
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED WITH CHEST PAIN OF AN UNKNOWN NATURE. UPON DEVICE INTERROGATION, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE CAPTURING IN THE ATRIUM AND HAD DISLODGED. THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE NON-FUNCTIONAL. AT THAT TIME, THE PHYSICIAN HAD NOT DETERMINED NEXT STEPS. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DISLODGED LV LEAD WAS FOUND TO BE ACUTELY PULLED BACK INTO THE ATRIUM. THE LV LEAD WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145797 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1861| 4543| 4592| E110| N141| 0147| 1283| 4034| 4053