BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 2153226 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06390
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    December 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THREE MONTHS LATER DURING A NORMAL PULSE GENERATOR REPLACEMENT PROCEDURE, THE LEAD WAS SURGICALLY ABANDONED DUE TO THE PREVIOUSLY REPORTED ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED APPROXIMATELY ONE MONTH LATER STATING NOISE WAS ALSO OBSERVED WITH THE LEAD SAFETY SWITCH. TECHNICAL SERVICES RECOMMENDED RESETTING THE SAFETY SWITCH AND TESTING THE LEAD FURTHER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE ATRIAL LEAD SAFETY SWITCH WAS TRIGGERED. ATRIAL IMPEDANCE MEASUREMENTS WERE AVERAGING APPROXIMATELY 650 OHMS WITH THE LOWEST MEASUREMENT AT 220 OHMS. NOISE WITH MANY ATRIAL TACHY RESPONSES WERE ALSO OBSERVED ON THE ATRIAL LEAD. TECHNICAL SERVICES DISCUSSED WHAT VALUES TRIGGER THE SAFETY SWITCH AND DISCUSSED FURTHER TESTING. IT WAS NOTED THAT THE LEAD ISSUE MAY NOT BE ADDRESSED UNTIL THE DEVICE REACHES REPLACEMENT INDICATOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR 4285| 4064| 1298