BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3043576 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02311
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WAS PERFORMED THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED BY VISUAL INSPECTION. ANALYSIS CONCLUDED THAT THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND WAS FOUND TO HAVE DISLODGED AFTER THE POCKET WAS SUTURED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145088 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R N140| 4470| 0276| 4592