BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1813573 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08895
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    August 7, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. 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 ATRIAL LEAD WAS NOT FUNCTIONING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD EXPIRED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5034 IMPLANTABLE PACING LEAD