BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11195154 · Received January 19, 2021

    Report

    Report Number
    3006630150-2021-00060
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    November 3, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7103648.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING PAIN AND SKIN IRRITATION DUE TO SEVERE REACTION WITH THE BANDAGES. IT WAS ALSO NOTED THAT THE PATIENT HAD AN INFECTION ON BOTH INCISION SITES. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED BUT RATHER DUE TO ALLERGIC REACTION TO BANDAGES. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A TRIAL LEAD REMOVAL AND WAS DOING WELL POSTOPERATIVELY. ALL PRODUCTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91659 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7100003 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention