BEUDAMED
    FDA Recall Open, Classified

    Vanta Implantable Neurostimulator (INS), Model 977006

    Recall: Z-0132-2025 · Initiated August 21, 2024

    Recall

    Recall Number
    Z-0132-2025
    Event Number
    95281
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 21, 2024
    Posted
    October 17, 2024
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Vanta Implantable Neurostimulator (INS), Model 977006

    Reason

    Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 08/21/2024 via letter and email. The notice explained the issue, recommended mitigation, and requested the following: Required Actions: " Ensure that the Device Eligibility screen in the Model A71300 Clinician Programmer application is used during the trialing evaluation to review compatible INSs that will allow the same parameters used during the trial evaluation. " Ensure that the battery longevity tools in the Model A71200 Clinician Programmer application are used during each patient visit, to keep track of the estimated longevity of the Vanta INS. " Ensure that the patient understands the impact of therapy changes on the battery life of the Vanta INS. " Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information.

    Distribution

    Worldwide distribution.

    Quantity

    11789 units