BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETERNA 16-CHANNEL IPG

    MDR report key: 17962344 · Received October 18, 2023

    Report

    Report Number
    1627487-2023-04933
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 25, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067040763
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT HAD SWELLING AND AN INFECTION AT THE IPG SITE WAS REPORTED TO ABBOTT. THE PATIENT WAS GIVEN ANTIBIOTICS. THE INFECTION HAS RESOLVED. AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF THE IPG. BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. INFORMATION REQUESTED, BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 0

    A PATIENT HAD SWELLING AND AN INFECTION AT THE IPG SITE WAS REPORTED TO ABBOTT. THE PATIENT'S IPG WAS EXPLANTED AND GIVEN ANTIBIOTICS. THE INFECTION HAS RESOLVED. AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF THE IPG. BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING AND AN INFECTION AT THE IPG SITE. PATIENT WAS GIVEN ANTIBIOTICS. IN A RECENT UPDATE, IT WAS REPORTED THAT THE INFECTION HAS RESOLVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT THE INFECTION AT THE IPG SITE DID NOT RESOLVE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT WAS ALSO REPORTED THAT THE INFECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652992 ETERNA 16-CHANNEL IPG SCS IPG LGW ABBOTT MEDICAL 32400 9202011 05415067040763

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other SCS LEAD.