BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1843384 · Received September 24, 2010

    Report

    Report Number
    2649622-2010-09049
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    July 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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 BIMONTHLY 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 THAT THE PATIENT CALLED TO REPORT BEEPING TONES FOLLOWING PROGRAMMING OF HIS DEVICE. THE PATIENT WAS REFERRED TO HIS PHYSICIAN. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 24 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT BEEPING TONES FOLLOWING PROGRAMMING OF HIS DEVICE. THE PATIENT WAS REFERRED TO HIS PHYSICIAN. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 24 DAYS LATER. DEATH CERTIFICATE LATER REVEALED THE CAUSE OF DEATH TO BE TERMINAL ARRHYTHMIA WITH UNDERLYING CAUSES OF ELECTROLYTE IMBALANCE, RENAL FAILURE, AND (B)(6) .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death