BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONOX LV-T

    MDR report key: 2052492 · Received March 15, 2011

    Report

    Report Number
    1028232-2011-00537
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    UPON INTERROGATION THE DEVICE REPORTS ERI. THE DEVICE ALSO REPORTS THAT THERE ARE 73 DAYS REMAINING UNTIL ERI. THE BATTERY VOLTAGE IS 5.77 V. DEVICE EXPLANT WAS RECOMMENDED. ON (B)(6) 2011 - WE WERE INFORMED THAT THIS DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRONOX LV-T LV LEAD MRM BIOTRONIK SE & CO. KG 347406

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization