BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 7399861 · Received April 5, 2018

    Report

    Report Number
    1028232-2018-01187
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 13, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    PMA / PMN Number
    K152995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT THE BIOMONITOR II WAS INTERROGATED REVEALING NO ANOMALIES. THE BATTERY STATUS WAS FOUND TO BE 85%. FURTHERMORE, THE ANALYSIS OF THE DEVICE MEMORY SHOWED NO PECULIARITIES. DURING THE FURTHER COURSE OF THE ANALYSIS AN ELECTRICAL END-TEST WAS PERFORMED. DURING THE TEST AN ELEVATED CONTACT RESISTANCE BETWEEN THE CAN OF THE BIOMONITOR II AND ELECTRODE WAS NOTED INDICATING A DAMAGED ELECTRONIC CIRCUITRY WHICH WAS CONFIRMED AFTER OPENING THE DEVICE. THE KIND OF DAMAGE CLEARLY INDICATES AN ELECTRICAL OVERSTRESS BY THE REPORTED EXTERNAL DEFIBRILLATION. PLEASE NOTE, THAT BY DESIGN THE DEVICE IS PROTECTED AGAINST HARM FROM AN EXTERNAL DEFIBRILLATION OR ELECTROCAUTERY. CONSIDERING THE EXTREMELY HIGH ELECTRICAL FIELDS, A DAMAGE AGAINST THE DEVICE CANNOT BE EXCLUDED TOTALLY. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE WITHIN SPECIFICATION. IN SUMMARY, THE DEVICE WAS RECEIVED ELECTRICALLY DAMAGED, MOST LIKELY DUE TO THE OCCURRENCE OF ELECTRICAL OVERSTRESS SUCH AS THE REPORTED EXTERNAL DEFIBRILLATION. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THIS SERIAL NUMBER SHOWED NO ANOMALIES. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. 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

    THIS DEVICE WAS EXPLANTED BECAUSE IT STOPPED SENSING, POST CARDIOVERSION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241782 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization