BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1841911 · Received September 23, 2010

    Report

    Report Number
    2649622-2010-09037
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    August 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION SUBSEQUENTLY RECEIVED ON 9/21/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT HIS "DEVICE ISN'T WORKING RIGHT. HE'S IN (B)(6) THEY HAVE HIM HOOKED-UP TO A MONITOR AND YOU CAN SEE THE SPIKES." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 6 DAYS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death