BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2172967 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11234
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS LEAD WAS SURGICALLY ABANDONED. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEAD EXHIBITED INCREASE IN PACE IMPEDANCE (ALTHOUGH REMAINING WITHIN NORMAL LIMITS) AND INCREASE IN THRESHOLDS, AS WELL AS LOSS OF CAPTURE. THE ASSOCIATED MEDICAL DEVICE REQUIRED RE-PROGRAMMING AT THE OFFICE VISIT TO UNIPOLAR DUE TO THE ELEVATED IMPEDANCES. IT TURNED OUT THAT THIS LEAD HAD A CONDUCTOR FRACTURE. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION BEYOND THE NECESSITY FOR EARLY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention S606| 1270| 4470| 4053| 4034