BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2173845 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10808
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO INTERMITTENT LOSS OF CAPTURE. IT WAS ALSO REPORTED THE PATIENT HAD EXPERIENCED SOME SYNCOPAL EPISODES WITH AN UNKNOWN CAUSE. THE PATIENT HAD AN SINUS RHYTHM WITH FIRST DEGREE HEART BLOCK AT A RATE OF 65 BPM. THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R S203| 4034| 1298| 4063