BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3100192 · Received May 8, 2013

    Report

    Report Number
    2124215-2013-02856
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THIS LEFT VENTRICULAR (LV) LEAD WAS FRACTURED WITH HIGH IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. THE PHYSICIAN WAS SENDING THE PATIENT FOR CONSULT. THE PATIENT WAS RECOVERING FROM FLU AND PROBABLY DID NOT FEEL ANY LOSS OF LEAD FUNCTION AS REPORTED. NO REVISION WAS DONE YET. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE PHYSICIAN WILL NOT DO THE REVISION OR ANYTHING TO THE PATIENT DUE TO PATIENT'S AGE. THE PATIENT AND THE FAMILY WANTED TO AVOID ANY POSSIBLE SURGERIES. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201277 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR 4456| H120| S601| 4554