BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1851741 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14231
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED. ANALYSIS IS ON GOING.

    Additional Manufacturer Narrative · 1

    AS OF TODAY THE LEAD HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS INDICATED THAT THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. VISUAL INSPECTION CONFIRMED FRACTURES AT 359.3, 359.4, 359.6, 359.9 AND 360.1 MM FROM THE TERMINAL PIN. ADDITIONAL DAMAGE WAS NOTED AT THIS SAME LOCATION WHICH INCLUDED DEFORMED CONDUCTOR COILS. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED AND THE INFORMATION REPORTED WITH THE LEAD, IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO HIGH, OUT OF RANGE PACING IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR N119| H170| 4087| 0185| 4136| 4592| 4555