BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2151471 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06101
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL ANALYSIS REVEALED DEFORMED CONDUCTOR COILS AND SURFACE ELECTRO-CAUTERY DAMAGE, BOTH OF WHICH WERE NOTED BY LABORATORY TECHNICIANS TO LIKELY HAVE BEEN INDUCED BY THE FIELD DURING EXPLANT. DRIED BLOOD WAS ALSO NOTED TO BE IN THE LUMEN OF THE LEAD, AND THEREFORE THE GUIDEWIRE INSERTION TEST WAS NOT PASSED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE FIELD ALLEGATION OF DISLODGEMENT COULD NOT BE CONFIRMED BY LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED. 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 THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO LEAD DISLODGEMENT, WHICH ADDITIONALY WAS CAUSING MUSCLE STIMULATION. THE LEAD WAS REPLACED. NO ADVERSE PATIENT EFFECTS CONCERNING TO THE PROCEDURE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4548| 4554| 5076| H120| 4542| 4076