BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 1039679 · Received May 9, 2008

    Report

    Report Number
    2182208-2008-00139
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    March 20, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. EVALUATION SUMMARY: BATTERY DEPLETION WAS NORMAL. OUTER INSULATION BREACHED DEPRESSION; PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. OUTER INSULATION BREACHED DEPRESSION; PROXIMAL SEGMENT WAS RETURNED FOR ANALYSISIT WAS REPORTED THAT THE PT EXPIRED AND THE PARENTS HAVE VERBALLY BLAMED THE DEVICE. FOLLOW-UP WITH THE HCP INDICATES THE PT HAD A LONG HISTORY OF CONGENITAL HEART CONDITIONS AND RECENTLY UNDERWENT GALLBLADDER SURGERY AFTER WHICH TIME, THE PT COMPLAINED OF STOMACH PAIN. THE PT HAD TWO PACING SYSTEMS IMPLANTED (ONE WAS ABDOMINAL IMPLANT; THE OTHER SYSTEM WAS UNDER HER RIBS). CONSIDERING THE PT'S COMPLAINTS OF STOMACH PAIN, THE PHYSICIAN CHANGED THE ACTIVE PACING SYSTEM FROM THE ABDOMINAL SOURCE TO THE PACEMAKER WHICH WAS UNDER THE PT'S RIBS. AN AUTOPSY WAS DONE AND THE RESULTS AND CAUSE OF DEATH HAVE BEEN REQUESTED BUT NOT RECEIVED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION COMPONENT/SUBASSEMBLY FAILURE (SELECT SPECIFIC CODE FROM CATEGORY D) INSULATION NO CONCLUSION CAN BE DRAWN OTHER (AN APPROPRIATE DEVICE CODE CANNOT BE IDENTIFIED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED AND THE PARENTS HAVE VERBALLY BLAMED THE DEVICE. FOLLOW-UP WITH THE HCP INDICATES THE PT HAD A LONG HISTORY OF CONGENITAL HEART CONDITIONS AND RECENTLY UNDERWENT GALLBLADDER SURGERY AFTER WHICH TIME, THE PT COMPLAINED OF STOMACH PAIN. THE PT HAD TWO PACING SYSTEMS IMPLANTED (ONE WAS ABDOMINAL IMPLANT; THE OTHER SYSTEM WAS UNDER HER RIBS). CONSIDERING THE PT'S COMPLAINTS OF STOMACH PAIN, THE PHYSICIAN CHANGED THE ACTIVE PACING SYSTEM FROM THE ABDOMINAL SOURCE TO THE PACEMAKER WHICH WAS UNDER THE PT'S RIBS. AN AUTOPSY WAS DONE AND THE RESULTS AND CAUSE OF DEATH HAVE BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O 4968 IMPLANTABLE PACING LEAD| ADDRL1 IMPLANTABLE PULSE GENERATOR