BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENOX VR-T

    MDR report key: 1012889 · Received March 10, 2008

    Report

    Report Number
    1028232-2008-00209
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    September 5, 2007
    Report Date
    February 8, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD INITIALLY UNDERWENT A VISUAL INSPECTION, WHICH REVEALED SIGNS OF WEAR ON THE ICD HOUSING. THIS IS AN INDICATION OF POTENTIAL WEAR FROM THE LEAD INSULATION. THE ICD STATUS WAS INTERROGATED, WHICH REVEALED THE DEVICE STATUS MOL2 AFTER A 7-MONTH IMPLANTATION PERIOD. THE CONTENTS OF THE ICD MEMORY WERE VERIFIED. THE VENTRICULAR IEGM REVEALED ARTIFACTS. THE SHOCK TABLE DOCUMENTED AT LEAST 336 INTERRUPTED CHARGING PROCESSES. LATER ON IN THE ANALYSIS, THE ICD SIGNAL SENSING WAS CHECKED AND WAS FOUND TO BE NOISE-FREE. THE ICD RECORDED THE SIGNALS TRANSMITTED WITHOUT ANY NOISE. THE ICD'S THERAPY CAPABILITY WAS CHECKED. THE ANTIBRADYCARDIA OUTPUT SIGNAL WAS WORKING PERFECTLY AND CORRESPONDED TO THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS TRANSMITTED AND THE DEVICE REACTED AS PER SPECS WITH A 30 JOULE DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS ATTAINED. THE 9 S CHARGE TIME WAS TYPICAL. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR MFG DEFECT. THE ICD WAS FULLY FUNCTIONAL. IN SUMMARY, THERE IS NO DEVICE DEFECT. OF SPECIAL NOTE, SIGNAL SENSING WORKED PERFECTLY.

    Description of Event or Problem · 1

    SIGNIFICANT CAPACITOR CHARGING WITH INADEQUATE VP DETECTION AFTER A LEAD HAD ALREADY BEEN EXTRACTED AND A NEW ONE IMPLANTED IN EARLY 2007. PHYSICIAN SUSPECTS AICD DEFECT (CONNECTION). SUSPECTED LEAD INSULATION DEFECT. WHEN EXPLANTING THE SYSTEM, THE ACTUAL PERSON IMPLANTING THE DEVICE WAS, HOWEVER, ABLE TO DETERMINE AN INSULATION DEFECT ON THE LEAD. ALSO REMOVED: LINOX T 65, MDR 1028232-2008-00210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENOX VR-T ICD LWS BIOTRONIK GMBH AND CO. 346999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization