BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 17994136 · Received October 24, 2023

    Report

    Report Number
    3006630150-2023-06495
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    July 25, 2019
    Report Date
    October 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: 5093187. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11600. MODEL: SC-1160. SERIAL: (B)(6). BATCH: 355694.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THERE WAS A HIGH IMPEDANCE ON ONE OF THE PATIENTS LEADS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396930 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5077556 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention