BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 4140219 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16832
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LV LEAD WILL NOT BE RETURNED FOR ANALYSIS. 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 ONE THIS PATIENT¿S LEFT VENTRICULAR (LV) LEAD WAS OBSERVED TO HAVE DISLODGED AND NOT CAPTURING AT MAXIUMUM OUTPUTS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620595 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4470| 0696| P162| 4592