BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10755264 · Received October 29, 2020

    Report

    Report Number
    3006630150-2020-05245
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-70E, SERIAL: (B)(4), BATCH: 7072401.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING EXCRUCIATING PAIN AND WAS HAVING AN ELEVATED BLOOD PRESSURE. THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS PAIN MEDICINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221132 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7072347 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention