BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19245169 · Received May 5, 2024

    Report

    Report Number
    3006630150-2024-02867
    Event Type
    Injury
    Date Received
    May 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    May 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7081002, PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74 ,SERIAL: (B)(6), BATCH: 7076348/7076646.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PARESTHESIA IN THE RIB CAGE DUE RIGHT SIDED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEAD WAS REPOSITIONED. NO PRODUCT WAS ADDED OR REMOVED. THE PATENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811158 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7080982 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention