BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 1951573 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23574
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    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 ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. 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 THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED SYNCOPE AND PRESENTED TO THE EMERGENCY ROOM. UPON TESTING, THE LEAD DISPLAYED IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND A LEAD FRACTURE WAS SUSPECTED. HIGH THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE WERE ALSO NOTED. THE LEAD WAS ABANDONED SURGICALLY AND REPLACED WITH A NEW LEAD.

    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 82 YR Hospitalization| L| R 4035| 1296| 1273| 4054| 4135| 4136| S603