BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 4145092 · Received October 6, 2014

    Report

    Report Number
    2124215-2014-14170
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    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 RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATED THE RV LEAD WAS DAMAGED AND CUT DURING LASER EXTRACTION, BUT NO SPECIFIC LEAD LOCATION GIVEN. FURTHER, THE FIELD REPRESENTATIVE DID NOT KEEP THE EXPLANTED LEAD THUS IT WILL NOT BE RETURN. THE RV LEAD WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624531 SELUTE PICOTIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4470| 1298| 4035| S606| 4053| 4063