BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 4232389 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19597
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 30, 2014
    Report Date
    November 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SENSING MEASUREMENTS HAD BEEN LOW. 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 DURING AN RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715252 SWEET PICOTIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR E110| 4086| 4054| 0292| 4542| 0157| N140| T125