BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1952805 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23987
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE OBSERVED DURING THE PROCEDURE. 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 RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 5076| 4082| 7074| MISMATCH| 4269| 1283| 4210| 1296