BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3041192 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00941
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    November 27, 2012
    Report Date
    February 21, 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

    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. INITIAL VISUAL ANALYSIS NOTED THE CONDUCTOR COILS WERE DEFORMED AND THE INSULATION BENT 440 MILLIMETERS FROM THE TERMINAL PIN DUE TO INDUCED DAMAGE DURING THE PROCEDURE. THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGMENT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE MONTH AFTER THE IMPLANT OF THIS LEFT VENTRICULAR LEAD, HIGH THRESHOLDS WERE NOTED. UPON INVESTIGATION OF THE ISSUE BY X-RAY, IT WAS CONFIRMED THE LEAD HAD DISLODGED. THE LEAD WAS INITIAL PROGRAMMED OFF UNTIL A REVISION PROCEDURE COULD TAKE PLACE. DURING THE REVISION, THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, HOWEVER THE LEAD KINKED AND WAS FULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142547 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R