BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 1953969 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24127
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD EXPERIENCED DIFFICULTY UPON REMOVAL FROM THE ASSOCIATED DEVICE HEADER DURING A REPLACEMENT PROCEDURE. SALINE AND MINERAL OIL WERE UTILIZED TO LOOSEN THE LEAD AND AFTER SOME TIME OF WORKING THE LEAD BACK AND FORTH IT FINALLY RELEASED FROM THE HEADER. UPON EXTRACTION, THE TERMINAL PIN HAD SEPARATED FROM THE BODY OF THE LEAD EXPOSING THE INTER CONDUCTOR WIRES. THIS LEAD WAS SEVERED DISTAL TO THE TERMINAL PIN AND CAPPED. A NEW LEAD WAS INSERTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 1176| 4064| 4035