BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3910470 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09153
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 REVISED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE THAT THIS LV LEAD WAS DISLODGED DURING CALVE REPLACEMENT. THE PHYSICIAN WAS NOT ABLE TO REPOSITION THE LEAD DUE TO STENOSIS AT SUBCLAVIAN AND LASER EXTRACTION WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THIS LV LEAD WAS ABANDONED SURGICALLY AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387909 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4473| N119| 0157| T125| 4592