BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2163307 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07401
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    July 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS SCHEDULED FOR ANOTHER FOLLOW APPOINTMENT IN TWO MONTHS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THREE MONTHS LATER, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD FRACTURED. IMPEDANCE MEASUREMENTS HAVE INCREASED OVER THE LAST YEAR AND THRESHOLD MEASUREMENTS ARE ALSO AT HIGHER VALUES WITH LOWER R-WAVE MEASUREMENTS. THE PATIENT IS NOT PACEMAKER DEPENDENT SO NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED. THE DEVICE WAS REPROGRAMMED TO HIGH OUTPUTS AND AV DELAY TO REDUCE PACING AS MUCH AS POSSIBLE PER THE PHYSICIAN'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R 4039| 1297| 4035