BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3911723 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-10055
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE THAT THIS LV LEAD WAS EXPLANTED DUE TO DISLODGEMENT. FURTHERMORE, PHYSICIAN TRIED REPOSITIONING THE LV LEAD DUE TO HIGH THRESHOLD MEASUREMENTS HOWEVER WAS UNSUCCESSFUL. THIS LV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390663 ACUITY IMPLANTABLE HF LEADS LWP CPI - DEL CARIBE 4593

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R V173| 4544| 4593| 4470