BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2041829 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01431
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THE LEAD AND THE ASSOCIATED PACEMAKER WERE BOTH REMOVED FROM SERVICE AS THE CAUSE OF THE OUT OF RANGE IMPEDANCES COULD NOT BE DETERMINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4053

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)