BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1043566 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33075
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    December 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD DISPLAYED INCREASED PACING THRESHOLD MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WAS TOLD BY PHYSICIANS AND TECHNICIANS THAT THERE WAS A BROKEN LEAD. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R THE DEVICE 4285/240640 WAS IMPLANTED 09-JAN-1998| THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE 1280/534817 WAS IMPLANTED 09-MAY-2002