BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 3211057 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07818
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ONLY THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND THE TERMINAL PIN WAS MISSING. VISUAL INSPECTION REVEALED THE COILS WERE STRETCHED DUE TO A DUCTILE FRACTURE, CONFIRMING THE REPORTED CLINICAL ALLEGATION. DRIED BODY FLUID WAS NOTED THROUGHOUT THE ENTIRE LEAD LUMEN. IN ADDITION, THE CONDUCTOR COILS WERE DEFORMED AT 177 MM FROM THE ANODE ELECTRODE; LIKELY DUE TO A GRABBING TOOL. ANALYSIS CONFIRMED THE REPORTED CLINICAL ALLEGATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NON-BOSTON SCIENTIFIC DEVICE REPLACEMENT PROCEDURE, DIFFICULTY WAS ENCOUNTERED REMOVING THIS ATRIAL LEAD ALTHOUGH THE SET SCREWS WERE FULLY OPENED. THE SET SCREWS WERE REMOVED AND MEDICAL SILICON OIL WAS FLUSHED INTO THE SETSCREW HOLDERS, HOWEVER THE LEAD COULD NOT BE REMOVED AND FRACTURED AT THE CONNECTOR. IT WAS THOUGHT THIS WAS DUE TO A SET SCREW ISSUE. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310930 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4244

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 1010| 1283| 030-247| 0950| 0465| 4285