BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTA

    MDR report key: 19286130 · Received May 10, 2024

    Report

    Report Number
    2182207-2024-02549
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 10, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT WHEN COMMUNICATION BETWEEN COMMUNICATOR AND INS WAS PERFORMED, "THE STIMULATOR WILL NOT BE FOUND" DISPLAYED. THERE WERE NO PROBLEMS WITH CHARGING THE INS OR COMMUNICATOR, AND THE COMMUNICATION COULD BE ESTABLISHED EVEN IN SHORT DISTANCES. THE DOCTOR ASKS IF THIS IS DUE TO INTERFERENCE WITH THE SPINAL IMPLANT PRODUCT. THE INS IMPLANTATION SITE WAS SLIGHTLY ABOVE THE BELTLINE, CREATING A POCKET 5 TO 7 CM NEAR THE DORSAL SPINE TO THE LEFT LATERAL REGION. THE PATIENT HAS TITANIUM IMPLANTS SUCH AS ¿LOTS¿, SCREWS, AND GAUGES IN THE SPINE. THE DISTANCE BETWEEN THE INS AND THE SPINAL IMPLANT PRODUCT WAS CLOSE. WHEN COMMUNICATOR WAS OPERATED ON THE IMPLANT SIDE (LEFT SIDE), COMMUNICATION WAS ALMOST POSSIBLE. WHEN THE DEVICE WAS OPERATED ON THE OPPOSITE SIDE, "NOT FOUND" OFTEN DISPLAYED. THE PHYSICIAN WAS CONCERNED THAT THERE MAY BE INTERFERENCE IF THERE WAS A SPINAL IMPLANT PRODUCT BETWEEN THE INS AND THE COMMUNICATOR. IT WAS NOTED THAT THE COMMUNICATOR MAY ALSO STOP DURING COMMUNICATION BUT WAS SOLVED BY CLOSING THE APP AND RE-OPERATING IT. TROUBLESHOOTING WAS PERFORMED. THE PATIENT WAS TOLD TO CONDUCT SEVERAL COMMUNICATION TESTS AND TO OPERATE THE COMMUNICATOR ON THE LEFT SIDE. NO ACTION WAS TAKEN. ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMAT ION WAS RECEIVED REPORTING IT WAS UNKNOWN IF THERE WAS A CONFIRMED INTERFERENCE BETWEEN THE INS AND SPINAL IMPLANT PRODUCTS. ACCORDING TO AN ENGINEER, "IT IS UNLIKELY THAT THERE WOULD BE ANY IMPACT. ANY SHIELDING, NOT JUST IMPLANTS, WILL IMPEDE COMMUNICATION.'' CAUSE WAS UNKNOWN. ACTION TAKEN WAS PERFORM COMMUNICATION ON THE SIDE WHERE THE INS WAS IMPLANTED. OUTCOME RESPONSE WAS "IT HAPPENS OC CASIONALLY SO WE'RE IN TROUBLE." IT WAS FURTHER REPORTED THAT FOR ANY ADDITIONAL ACTIONS TAKEN WERE "ON THE SIDE WHERE THE INS WAS IMPLANTED, THE PATIENT WAS OPERATING THE SMARTPHONE IN A CLOSER PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126229 VANTA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 977006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown