BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2910019 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15567
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING RISING IMPEDANCE MEASUREMENTS. IT IS UNKNOWN HOW HIGH THE MEASUREMENTS WERE. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITH A COMPETITIVE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17656 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4055

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R MISMATCH| T125| 4055| 1861| 0145