BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20024308 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05460
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50 . SERIAL: (B)(6). BATCH: 7071648. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70 . SERIAL: (B)(6). BATCH: 7082973..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND A CONTACT THAT WAS OUT. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF IN THE OPERATION ROOM. NO ELECTRO CAUTERY USED, AND PATIENT WAS DOING GREAT IN POST-OPERATIVELY GETTING GOOD RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179554 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7071648 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention