BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 19001005 · Received March 28, 2024

    Report

    Report Number
    3006630150-2024-01885
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7232052.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS TRIAL LEADS HAD MIGRATED WHICH WAS CONFIRMED BY THE PHYSICIAN. THE PATIENT WAS EXPERIENCING NAUSEA AND VOMITING DURING THE TRIAL PERIOD WHICH WAS BELIEVED TO HAVE CAUSED THE MIGRATION. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE WHICH SHOWED THAT ONE OF THE LEADS HAD FRACTURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221143 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7231928 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention