BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3211640 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07940
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A LEFT VENTRICULAR (LV) LEAD DISLODGEMENT WAS CONFIRMED IN A PREVIOUS FOLLOW-UP WITH THE DATE UNKNOWN TO THE CURRENT COMPANY FIELD REPRESENTATIVE. DISLODGEMENT WAS CONFIRMED BY ROUTINE X-RAY ANALYSIS. A LEAD REPOSITION PROCEDURE SUBSEQUENTLY FOLLOWED; HOWEVER, THE PHYSICIAN DECIDED TO EXPLANT THIS LV LEAD DUE TO THE ADDITIONAL OBSERVATION OF INSULATION DAMAGE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED AND THE FORMER LEAD WAS DISCARDED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED IN ASSOCIATION WITH THE DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310994 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R