BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 1953672 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23618
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD CURRENTLY REMAINS IMPLANTED AND THE PATIENT WILL BE SEEN AGAIN IN THREE MONTHS. 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 A NORMAL PATIENT FOLLOW UP, THIS RIGHT ATRIAL (RA) LEAD PRESENTED WITH AN INCREASE IN PACING IMPEDANCE MEASUREMENTS TO 1260 OHMS. AN X-RAY WAS TAKEN AND REVEALED THAT THE LEAD WAS BENT. IT IS SUSPECTED THAT THE LEAD HAS EXPERIENCED AN INCOMPLETE FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other (B)(4)| (B)(4)