BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORION RC SCS IPG

    MDR report key: 18062715 · Received November 3, 2023

    Report

    Report Number
    1627487-2023-05207
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    October 13, 2023
    Report Date
    February 21, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067040763
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF DEVICE HISTORY RECORDS (DHR), FOR ZFIN WORK ORDER#: (B)(4), PART#: 600183956 REV B, BATCH#: 9121583, AND ASSOCIATED LOWER-LEVEL ASSEMBLY ZSMI WORK ORDER#: (B)(4), PART#: 600054127 REV C, BATCH#: 9095306, WERE CONDUCTED AND NO ISSUES WERE FOUND. UNITS THAT WERE RELEASED INTO COMPONENT GOODS PASSED ALL MANUFACTURING VISUAL INSPECTION AND FUNCTIONAL TESTING REQUIREMENTS WITH NO ASSOCIATED REWORK OR NCMR. SPECIFICALLY, FOR S/N: (B)(6), DHR REVIEW CONFIRMS STERILIZATION REQUIREMENTS WERE MET. BASED ON THE INVESTIGATION PERFORMED, THERE IS NO INDICATION OF ANY NONCONFORMANCE FROM MANUFACTURING PROCESS, AND THEREFORE THE COMPLAINT CANNOT BE CONFIRMED TO BE A PLANO NEUROMODULATION MANUFACTURING RELATED EVENT.

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S WOUND AT THE IPG SITE WAS NOT HEALING. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200096 ORION RC SCS IPG SCS IPG LGW ABBOTT MEDICAL 32400 9121583 05415067040763

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other SCS ANCHOR (X2).| SCS LEAD (X2).