BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 740 VR-T DX PROMRI

    MDR report key: 16629145 · Received March 28, 2023

    Report

    Report Number
    1028232-2023-01530
    Event Type
    Death
    Date Received
    March 28, 2023
    Date of Event
    March 10, 2023
    Report Date
    June 8, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE LEAD IMPLANTED WITH THE ICD WAS STILL CONNECTED TO THE ICD HEADER. THE CONNECTIONS BETWEEN THE LEAD AND THE DEVICE WERE TESTED, PROVING THAT THE LEAD WAS CONNECTED PROPERLY. PRIOR TO THE ANALYSIS OF THE DEVICES, THE MANUFACTURING PROCESSES FOR THE LEAD AND THE ICD WERE RE-INVESTIGATED. ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING MANUFACTURING. PARTICULARLY THE FINAL ACCEPTANCE TESTS PROVED THE DEVICES FUNCTIONS TO BE AS SPECIFIED. THE LEAD AND THE ICD WERE DISCONNECTED FROM EACH OTHER AND SUBJECTED TO ANALYSIS. ANALYSIS OF THE LEAD LINOX SMART PROMRI S DX 65/17 THE LEAD WAS THOROUGHLY INSPECTED AND WAS FOUND COVERED IN BODY TISSUE IN SEVERAL POSITIONS. THE ANALYSIS REVEALED A WORN INSULATION AT 22 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN PARTICULAR AT THIS POSITION THE CONDUCTOR CABLE TO THE RV SHOCK COIL WAS FOUND FRACTURED AND A MOLTEN SPOT WAS OBSERVED ON THE CONDUCTOR CABLE. BASED ON THE CHARACTERISTICS, AS WELL AS THE LOCATION OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD WAS SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF INTERACTION WITH THE GENERATOR HOUSING. AFTER A LONG IMPLANTATION TIME OF 124 MONTHS SIGNS OF WEAR ARE A KNOWN RISK OF ICD THERAPIES. IN ADDITION, CALCIFIED APPEARING TISSUE RESIDUALS WERE FOUND APPROXIMATELY 32 CM TO 35.5 CM AND 40 CM TO 41.5 CM DISTAL TO THE IS-1 CONNECTOR PIN WHICH HAD IMPACT ON THE MANEUVERABILITY OF THE LEAD AND PRESUMABLY LED TO EXCESSIVE MECHANICAL STRESS IN THE IMPLANTED STATE. FURTHERMORE, CUTS IN THE INSULATION AND A BENT FIXATION HELIX WERE OBSERVED WHICH MOST LIKELY OCCURRED DURING THE EXTRACTION PROCEDURE. ANALYSIS RESULTS OF THE ICD LUMAX 740 VR-T DX PROMRI THE ICD WAS VISUALLY INSPECTED. THE INSPECTION REVEALED A SPOT OF MOLTEN TITANIUM ON THE ICD HOUSING. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS, CONFIRMING THAT THE DEVICE COULD NOT BE INTERROGATED. BASED ON THE OBSERVED SYMPTOMS AND CONSISTENT WITH THE ANALYSIS RESULTS OF THE RIGHT VENTRICULAR LEAD, A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT CAUSED BY THE CONTACT BETWEEN THE ICD AND THE WORN OUT LEAD LED TO A DAMAGE OF THE ELECTRONIC MODULE OF THE ICD. AS A RESULT OF THE DAMAGE THE DEVICE COULD NOT BE INTERROGATED. DUE TO THE LACK OF INTERROGATION OF THE ICD, NO CONCLUSION COULD BE DRAWN REGARDING THE REPORTED PATIENTS OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RESUSCITATED AND BROUGHT INTO THE HOSPITAL ON (B)(6) 2023. THE ICD CANNOT BE INTERROGATED. THE PATIENT WAS IN A BAD NEUROLOGICAL STATE AFTERWARDS. THE PATIENT DIED ON (B)(6) 2023. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427066 LUMAX 740 VR-T DX PROMRI ICD LWS BIOTRONIK SE & CO. KG 381463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death