BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 12572785 · Received October 4, 2021

    Report

    Report Number
    3006630150-2021-05558
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7132812.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT EXPERIENCED PAIN WHICH WAS NOT AN ISSUE PRE TRIAL. THE PAIN WAS NOT DEVICE RELATED AND THE CAUSED WAS UNKNOWN, HOWEVER THE PATIENT DID HAVE SCAR TISSUE THAT THE PHYSICIAN HAD TO PUSH THROUGH. THE PAIN DID NOT SUBSIDE DESPITE PAIN MEDICATION AND LIDOCAINE CREAM. THE PATIENT HAD A LEAD PULL AND WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469470 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7132463 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention