BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 1732800 · Received June 23, 2010

    Report

    Report Number
    6000144-2010-03013
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    June 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND. AS INDICATED IN TECH SERVICE CALL REPORT, THE CHANGES IN IMPEDANCE AROUND THE (B)(6) 2010, TIMEFRAME ARE NOT CLEARLY INDICATIVE OF AN ISSUE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALERT WAS TRIGGERED AT 3AM ON (B) (6) 2010, FOR IMPEDANCE SLIGHTLY HIGHER THAN BASELINE PACING AND LV (LEFT VENTRICULAR) IMPEDANCES. A FULL ENERGY SHOCK WAS DELIVERED THAT RESULTED IN PACED EMD LIKE BEATS. THE PATIENT IS REPORTED TO HAVE DIED AND "NO INDICATION OF INTEGRITY ISSUE FOUND IN VF EPISODE." HOWEVER, "WITHOUT EXACT TOD, IMPEDANCE VALUES ARE NONSPECIFIC AND THEREFORE NONDIAGNOSTIC.' 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 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD