BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10209427 · Received June 29, 2020

    Report

    Report Number
    3006630150-2020-02695
    Event Type
    Injury
    Date Received
    June 29, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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-2316-50E, SERIAL: (B)(4), BATCH: 7092637.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRIAL POSTOPERATIVE PROGRAMMING, THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. FLUOROSCOPY WAS TAKEN AND SHOWED THAT THE PATIENTS LEAD HAD MIGRATED. THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION. THE PHYSICIAN OPTED TO REPLACE THE LEAD AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED TRIAL LEAD WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673376 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7092196 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention