BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3082763 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-06757
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED. IT WAS NOTED THAT THE OUTER CONDUCTOR COIL WAS DEFORMED. THE LEAD TIP HAS NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD LEAD TO DISLODGEMENT. THE ALLEGATION OF DISLODGEMENT AGAINST THE LEAD COULD NOT BE CONFIRMED BY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE FIELD REPRESENTATIVE THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO LEAD DISLODGEMENT SEVERAL WEEKS AFTER IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184631 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R 4592| 4087| 0295| 4554| N140