BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2040949 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00861
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE IS NO RETURN OF PRODUCT, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PRIOR TO A DEVICE REPLACEMENT PROCEDURE, ATRIAL LEAD NOISE WAS DISPLAYED. SENSING, IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL LIMITS. AFTER THE DEVICE POCKET WAS OPENED, THE ATRIAL PORT SEALING RING CAME OFF. IT WAS THOUGHT THE ATRIAL NOISE WAS DUE TO THE DAMAGED SEALING RING. FURTHER INVESTIGATION OF THIS LEAD COULD NOT BE PERFORMED, AS THE LEAD WAS PULLED BEFORE THE DISTAL SET SCREW WAS OPENED. REPORTEDLY, THERE WAS NO FORCE USED, HOWEVER THE LEAD SEVERED APART AND THE LEAD COULD NOT BE FURTHER INVESTIGATED. THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0148| H195| 4244| 4517