BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3213572 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10039
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    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 A GRADUAL INCREASE IN IMPEDANCES OVER A PERIOD OF TIME UNTIL IT EXCEEDED TO 2,000 OHMS RECENTLY AND IT PLUNGED TO AROUND 400 TO 500 OHMS RECENTLY. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED OF A POSSIBLE CAUSES OF LEAD FRACTURE. THERE WERE NO KNOWN CHANGE IN LV R-WAVE OR THRESHOLDS. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE PATIENT WILL BE MONITORED STILL AS THE PACING LEAD IMPEDANCE WENT BACK TO NORMAL RANGE AND THE LV PACING CONFIGURATION WAS NOT CHANGED THIS TIME. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313859 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR N119| 4470| 0181| 4555