BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC INTERSEPT 1351/CB

    MDR report key: 364181 · Received November 17, 2001

    Report

    Report Number
    MW4003140
    Event Type
    Death
    Date Received
    November 17, 2001
    Report Date
    November 17, 2001
    Manufacturer
    METRONIC AF BUSINESS
    Product Code
    JOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/18/2002: THIS IS IN RESPONSE TO THE LETTER REQUESTING INFO TO ASSIST IN EVALUATING AN INCIDENT THAT WAS REPORTED TO THE CENTER ON 11/17/2001. THE REPORT, #MW4003140 WAS CREATED AND CODED BY THE AGENCY AFTER A LETTER WAS RECEIVED FROM A PRIVATE INDIVIDUAL. NO MEDWATCH REPORT HAD BEEN RECEIVED. THE INFO PROVIDES NO HOSP OR HEALTHCARE PROFESSIONAL REFERENCE THAT ALLOWS MFR TO ACCURATELY LINK THE INFO TO A REPORT OR TO FOLLOW UP WITH THE FACILITY TO OBTAIN FURTHER INFO. MFR UNDERSTANDS AND SUPPORT THE NEED TO KEEP THE SOURCE OF INFO CONFIDENTIAL, BUT BASED ON THE INFO PROVIDED IN LETTER AND REPORT, MFR IS UNABLE TO POSITIVELY IDENTIFY THE EVENT AND RESPOND TO QUESTIONS.

    Description of Event or Problem · 1

    PT PASSED AWAY BECAUSE OF A MALFUNCTION OF DEVICE CALLED INTERSEPT 1351/CB. THE DR PERFORMING THE HEART SURGERY TOLD RPTR THAT THE DEVICE DID NOT OPERATE PROPERLY RESULTING IN THE DEATH. RPTR STATED THAT DEVICE LACKED A SAFETY VALVE. THIS DEVICE IS A CARDIOTOMY RESERVOIR USED DURING OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52197 MEDTRONIC INTERSEPT 1351/CB BLOOD FILTER CARDIOTOMY SUCTION LINE JOD METRONIC AF BUSINESS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death