BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2153531 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-08677
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO EROSION OF THE LEADS THROUGH THE DEVICE POCKET.. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    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 65 YR 4064| 1291| 4136| MISMATCH| 4035