BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2780624 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12510
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    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 THIS LEFT VENTRICULAR LEAD WAS NOTED TO HAVE PACING IMPEDANCES GREATER THAN 2000 OHMS ALONG WITH DIAPHRAGM STIMULATION. SENSING AND THRESHOLD LEVELS WERE NOTED TO BE NORMAL. ADDITIONALLY, AS THIS LEAD AND DEVICE HAVE BEEN IMPLANTED FOR LESS THAN 4 MONTHS, THIS MAY ALSO BE INDICATIVE OF A CONNECTION ISSUE. THE LEAD CONFIGURATION WAS REPROGRAMMED, WHICH BOTH RESOLVED THE DIAPHRAGM STIMULATION AND BROUGHT THE LEAD IMPEDANCE LEVELS BACK TO NORMAL RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4470| 0296| N160| 4555