BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORION RC SCS IPG

    MDR report key: 23720186 · Received December 4, 2025

    Report

    Report Number
    1627487-2025-05973
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    August 26, 2025
    Report Date
    February 19, 2026
    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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED OBSERVATION OF IPG NOT DELIVERING DESIRED STRENGTH WAS NOT DUPLICATED OR CONFIRMED. THE ROOT CAUSE OF THE OBSERVATION WAS NOT ASCERTAINED. A REVIEW OF THE IPG DIAGNOSTIC LOGS DID NOTE THE DEVICE LOGGED PULSE WIDTH ERRORS (PWE) AND VOLTAGE MULTIPLIER OVERHEAD (VMO) ERRORS. THIS CAN OCCUR DUE TO THE PROGRAMMING IN CONJUNCTION WITH THE IMPEDANCE VALUES OR PULSE TRAIN REQUEST. SYSTEM IMPEDANCE LOGGING WAS NOT ENABLED DURING THE IMPLANT PERIOD, SO IT WAS NOT POSSIBLE TO SEE IF THERE WERE IMPEDANCE ISSUES WITH THE LEAD. IT WAS ALSO NOTED THE ERRORS WERE OCCURRING ON PROGRAM ID#1. THE OUTPUT WAS MONITORED ON AN OSCILLOSCOPE AS RECEIVED AND WAS FOUND TO BE CONSISTENT WITH THE PROGRAMMING. A FOLLOW UP DIAGNOSTIC LOG WAS EXTRACTED AND NO ERRORS WERE NOTED. THE DEVICE WAS SUBJECTED TO A FUNCTIONAL TEST ON AUTOMATED TEST EQUIPMENT (ATE). THIS TESTER VERIFIES THE ELECTRICAL PERFORMANCE OF THE CONTROL/COMMUNICATION CIRCUITRY, OUTPUT SIGNAL INTEGRITY, ALL TEST STEPS PASSED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438502 ORION RC SCS IPG SCS IPG LGW ABBOTT MEDICAL 32400 T00006706 05415067040763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD