BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 10680723 · Received October 14, 2020

    Report

    Report Number
    1627487-2020-32607
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 10, 2020
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734402651
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND PATIENT INFORMATION. ADDITIONAL INFORMATION WAS NOT PROVIDED. IT WAS REPORTED THE ABBOTT CARE TEAM CALLED A PATIENT AND WAS TOLD THE PATIENT¿S SYSTEM WAS EXPLANTED IN NOVEMBER 2019 DUE TO IT ¿BREAKING" AND "NOT WORKING" ABOUT TWO YEARS AFTER IMPLANT. THE PATIENT DECLINED TO GIVE FURTHER INFORMATION. THE PATIENT DID NOT VERIFY PHI. THE CLINICAL SPECIALIST WAS NOT NOTIFIED. THE PATIENT DECLINED ANY FURTHER OUTREACH FROM ABBOTT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT AND EVENT INFORMATION. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURER NUMBER: 1627487-2020-32608. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED IN (B)(6) OF 2019 DUE TO THE SYSTEM "BREAKING" AND "NOT WORKING". FURTHER INFORMATION WAS NOT MADE AVAILABLE TO THE MANUFACTURER. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143609 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ABBOTT MEDICAL 3788 3837723 05414734402651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3219, SCS PADDLE LEAD