BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 2173367 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11056
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 (RA) LEAD CONTINUED TO EXHIBIT NOISE (AS NOTED ON STORED ELECTROGRAMS IN THE ARRHYTHMIA LOG BOOK); IT WAS THOUGHT THAT THE LEAD WAS FRACTURED. DURING AN UPGRADE TO A BI-VENTRICULAR DEVICE THIS LEAD WAS EXTRACTED, AND A NEW RA LEAD WAS IMPLANTED. IT WAS NOTED THAT THE WILL NOT BE RETURNED AS IT WAS SENT TO THE PATHOLOGY LAB AT THE HOSPITAL. NO ADDITIONAL 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 72 YR Hospitalization| L| R 5092| T167| 1861| 1273| 4136| 4244| N119| MISMATCH| 0148