BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3041168 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01692
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 15, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH VISUAL EVALUATION OF THE LEAD WAS PERFORMED. CUTS WERE NOTED IN THE INSULATION DUE TO THE REMOVAL OF THE SUTURE SLEEVE, HOWEVER THIS WAS INDUCED DURING THE REMOVAL. NO FURTHER TESTING WAS PERFORMED, HOWEVER IT WAS NOTED THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGMENT.

    Additional Manufacturer Narrative · 1

    THE LEAD WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LEAD DISLODGEMENT WAS NOTED ON THIS LEFT VENTRICULAR LEAD. A PROCEDURE WAS PERFORMED TO REVISE THE LEAD, HOWEVER AN INSULATION BREACH WAS NOTED ALLOWING BLOOD TO ENTER THE INSIDE OF THE LEAD. THE LEAD WAS FULLY EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144179 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R