BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3050016 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03533
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THIS LEAD REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. 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 DURING THE IMPLANT PROCEDURE, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING THRESHOLDS AFTER THE POCKET WAS CLOSED. FLUOROSCOPY REVEALED THE LEAD HAD PULLED BACK SLIGHTLY. THE LEAD MEASUREMENTS WERE STILL ACCEPTABLE. THE PHYSICIAN DETERMINED THE PATIENT WOULD REMAIN HOSPITALIZED TO ASSESS THE LV LEAD MEASUREMENTS AND POSITION, AND THE PATIENT WOULD BE CONSIDERED FOR AN EPICARDIAL LV LEAD IF THIS LEAD BECAME FURTHER DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153076 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1