BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12930261 · Received December 3, 2021

    Report

    Report Number
    3006630150-2021-06939
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    August 27, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT:PRODUCT FAMILY: SCS-LINEAR LEAD,UPN: M365SC2317500,MODEL: SC-2317-50,SERIAL: (B)(4),BATCH: 7070966.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE REPROGRAMMING DUE TO INCREASED PAIN. THE PATIENT WAS ALSO HAVING STIMULATION ON NON TARGETED AREAS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820753 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 3210604 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention