BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 4145470 · Received October 6, 2014

    Report

    Report Number
    2124215-2014-16066
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DISLODGED. THIS LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624082 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 0184| 4591| 4469| N119| 4592| 4542