BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3043245 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02988
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. UPON EVALUATION THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS WITH LOSS OF CAPTURE AND LOW IMPEDANCE. IT WAS FOUND THAT THE LV LEAD HAD DISLODGED AND MOVED INTO THE ATRIUM. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. THE PHYSICIAN OPTED TO NOT PLACE A NEW LV LEAD AND PLUGGED THE PORT INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145274 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 0185| N051| 4592| 4470