BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 3002757 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00271
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 28, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING 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 MANUFACTURING. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THIS PT'S DEVICE IS AT ERI AND WAS REPLACED WITH ANOTHER ICD. THERE WERE 8 SHOCKS (NOT INCLUDING TEST/INDUCTION SHOCKS) AND OUTPUT ON THE LEADS WAS AT 2.8 V AND 0.5 MS FOR BOTH A AND RV. THIS PT HAS A LOW PACING PERCENTAGE THOUGH (LESS THAN 35% IN A AND LESS THAN 5% IN V). THIS IS ALL THE AVAILABLE INFORMATION AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63943 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization