BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELUTE PICOTIP

    MDR report key: 3090655 · Received May 2, 2013

    Report

    Report Number
    2124215-2013-07332
    Event Type
    Death
    Date Received
    May 2, 2013
    Date of Event
    January 6, 2012
    Report Date
    April 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 PAPERWORK FROM THE PATIENT'S SON WHO REPORTED THAT THE PATIENT PASSED AWAY IN (B)(6) 2012 DURING A PROCEDURE TO REPLACE THE SYSTEM DUE TO INFECTION. DURING LASER EXTRACTION OF THE LEADS, A SUPERIOR VENA CAVA (SVC) DISSECTION OCCURRED RESULTING IN A PERICARDIAL TAMPONADE. THE SVC TEAR WAS REPAIRED WITH A SUTURE FOLLOWED BY AGGRESSIVE RESUSCITATION AND CPR EFFORTS, BUT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS ATTRIBUTED TO EXCESSIVE BLEEDING DURING THE PROCEDURE. A BOSTON SCIENTIFIC REPRESENTATIVE WAS NOT PRESENT AT THE PROCEDURE AND WAS NOT AWARE OF THE EVENT UNTIL RECENTLY AS THIS WAS A COMPETITOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191839 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| L| R 4034| 4053| 1273| 1290