BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORION RC SCS IPG

    MDR report key: 21527438 · Received March 5, 2025

    Report

    Report Number
    1627487-2025-01013
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067040763
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 1 OF 2 ANCHORS; HOWEVER, IT IS UNKNOWN WHICH ANCHOR, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS ANCHOR, MODEL: 1192, UDI: (B)(4), BATCH: 9110821.

    Additional Manufacturer Narrative · 0

    CORRECTION: HEALTH EFFECT - CLINICAL CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCING PAIN AT THE IPG SITE ALONG WITH DIFFICULTY REMEMBERING TO CHARGE THE IPG. DIAGNOSTIC TESTING REVEALED BOTH LEADS HAD MIGRATED AND THE LEFT ANCHOR HAD SNAPPED INTO TWO PIECES. AS RESULT, THE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY. IT IS UNKNOWN WHICH ANCHOR CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631276 ORION RC SCS IPG SCS IPG LGW ABBOTT MEDICAL 32400 8894102 05415067040763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR