BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2181943 · Received July 28, 2011

    Report

    Report Number
    2649622-2011-10887
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    February 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011 OF NOTE, THE REPORT OF INFECTION IS NORMALLY SUBMITTED VIA AN ASR THAT WOULD HAVE BEEN DUE ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT DIED THREE DAYS AFTER THE REPORT OF THE INFECTION. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH THIS EVENT NO LONGER QUALIFIES FOR ASR REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPETITOR THAT THE PATIENT HAD THREE LEADS REMOVED DUE TO INFECTION. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE INDICATED THE PATIENT DIED THREE DAYS AFTER THE LEADS WERE REMOVED DUE TO THE INFECTION. ADDITIONAL INFORMATION RECEIVED INDICTED THE PATIENT WAS ADMITTED INITIALLY FOR CHEST PAIN. THE PATIENT WAS GROWING PSEUDOMONAS PNEUMONIA AND IT WAS SUSPECTED THAT IT WAS ALSO IN THE POCKET WHICH IS WHY THE LEADS WERE REMOVED. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R