BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 2905474 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14563
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PATIENT UNDERWENT A DEVICE REPLACEMENT PROCEDURE. DURING THE REPLACEMENT, WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS BEING SEPARATED FROM THE DEVICE HEADER, THE PROXIMAL PIN AND LEAD BODY FRACTURED FROM ONE OTHER. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED ALONG WITH THE DEVICE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12378 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4054| 1298| 4053| K063| 4136