BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 1952226 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23502
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THIS RV LEAD WAS DISCARDED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. POSITIVE CONFIRMATION OF A POSSIBLE LEAD FRACTURE IS THEREFORE NOT AVAILABLE. INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED TO HAVE A KINK IN THE CONDUCTOR DURING A NORMAL MEDICAL DEVICE CHANGE OUT. THIS RV LEAD WAS REMOVED FROM SERVICE. THERE WERE NO FURTHER COMPLICATIONS FOR THE PATIENT AND NO PREVIOUS ALLEGATIONS REGARDING RV LEAD PRODUCT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)