BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2071442 · Received April 28, 2011

    Report

    Report Number
    2124215-2011-07458
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 17, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AND THE LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO FRACTURE, WHICH WAS BELIEVED TO HAVE HAPPENED SHORTLY AFTER THE INITIAL IMPLANT OF THIS LEAD. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND A SLOW VENTRICULAR TACHYCARDIA RATE WHICH WAS EXTERNALLY CONVERTED. THE LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND INCREASED THRESHOLD MEASUREMENTS. IT WAS NOTED THAT SENSING MEASUREMENTS WERE NORMAL. AN X-RAY WAS PERFORMED AND NO FRACTURE WAS NOTED. AT THIS TIME, THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THE LEAD REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R H220| 4543| 4548| 0158| 4087| 4592| 1861