BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3212446 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08766
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP IT WAS NOTED THAT THIS LEFT VENTRICULAR LEAD HAD DISLODGED AND HIGH PACING THRESHOLDS WERE NOTED. A PROCEDURE TOOK PLACE AND THE LEFT VENTRICULAR LEAD WAS NOT SUCCESSFULLY REPOSITIONED AND THUS WAS EXPLANTED. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312828 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R