BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3213115 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10458
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL NOT BE RETURNED. 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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS OF LESS THAN 100 OHMS. INSULATION DAMAGE WAS NOTED. DURING THE DEVICE REPLACEMENT PROCEDURE, THIS RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312184 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1