BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1946224 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20885
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. A REVISION PROCEDURE TOOK PLACE AND TWO EPICARDIAL LEADS OF ANOTHER MANUFACTURER WERE IMPLANTED. UPON CONNECTING THE LEADS TO THE DEVICE THERE WERE HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS DISPLAYED. THE CHRONIC LV LEAD WAS CONNECTED TO THE DEVICE AND THE GREATER THAN 2,000 OHMS REMAINED. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE LV LEAD WAS SURGICALLY ABANDONED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4543| 1488TC| MISMATCH| N119| 1590| (B)(6)| 4592