BEUDAMED
    FDA Adverse Event Death Summary report: N

    IPERIA 7 DR-T DF4 PROMRI

    MDR report key: 6063133 · Received October 28, 2016

    Report

    Report Number
    1028232-2016-04010
    Event Type
    Death
    Date Received
    October 28, 2016
    Report Date
    October 3, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND ANALYZED. THE MEMORY CONTENT OF THE ICD WAS INSPECTED,SHOWING A NORMAL DEVICE FUNCTION WHILE IMPLANTED AND IN SERVICE. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE ANALYSIS OF THE MEMORY CONTENT SHOWED A NORMAL DEVICE BEHAVIOR WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED BUT THE EXACT DATE OF DEATH AND CAUSE OF DEATH ARE UNKNOWN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716433 IPERIA 7 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392423

    Patients

    Seq Age Sex Outcome Treatment
    1 Death