BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 VR-T

    MDR report key: 3232174 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01944
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD 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 AS WELL AS ON THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THIS ICD 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. THE RETURNED DEVICE DATA HAVE BEEN ANALYZED. THE INSPECTION REVEALED THE PRESENCE OF NOISE IN THE VENTRICULAR AND FAR-FIELD CHANNELS, CONFIRMING THE CLINICAL OBSERVATION. THE DETECTION OF NOISE IN THE VENTRICULAR CHANNEL LED TO A SHOCK DELIVERY, AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE RECEIVED X-RAY IMAGES WERE INSPECTED. THE IMAGE CORRESPONDING TO THE STATUS OF THE SYSTEM A FEW DAYS AFTER IMPLANT REVEALED A NORMAL SLACK OF THE LEAD. THE IMAGE SHOWING THE STATUS OF THE SYSTEM PREVIOUS TO THE EXPLANTATION PROCEDURE REVEALED THAT THE ICD ROTATED SINCE THE DATE OF IMPLANT AND THE LEAD SLACK INCREASED NOTABLY, WHICH REPRESENTS A RISK OF LEAD FRACTURE. IN SUMMARY, THE ICD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. THE ANALYSIS OF THE RETURNED DEVICE DATA CORROBORATED THE CLINICAL OBSERVATION. THE RETURNED LEAD FRAGMENTS DID NOT SHOW ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 25 MONTHS AN INAPPROPRIATE SHOCK WAS REPORTED. LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED BUT ALL INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331084 LUMAX 540 VR-T ICD LWS BIOTRONIK SE & CO. KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization