BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 2780069 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12114
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS ACTIVELY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PROCEDURE TO REPLACE THIS PACEMAKER DEPENDENT PATIENT'S DEVICE, THE CALLER OBSERVED DROPPED BEATS AFTER INSERTING THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD INTO THE HEADER OF THE REPLACEMENT DEVICE. THE LEAD WAS REMOVED FROM THE DEVICE AND VISUAL INSPECTION OF THE DEVICE NOTED BLOOD IN THE HEADER. THE PHYSICIAN FLUSHED THE DEVICE AND LEAD AND PERFORMED LEAD TESTING WITH THE PACING SYSTEM ANALYZER (PSA) AND THE LEAD CHECKED OUT FINE. THE LEAD WAS RE-INSERTED INTO THE DEVICE, HOWEVER; A FEW DROPPED BEATS WERE STILL OBSERVED. THEREFORE, A NEW DEVICE WAS CONNECTED TO THE LEAD AND NO DROPPED BEATS WERE OBSERVED. THIS REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN SUSPECTED THERE WAS SOME INTERFERENCE ISSUE DUE TO THE BLOOD IN THE HEADER AND/OR A CONNECTION ISSUE WITH THE FIRST ATTEMPTED DEVICE. 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 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 1298| 4054| K173| 4053