BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 20719502 · Received November 19, 2024

    Report

    Report Number
    3006630150-2024-07958
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    May 27, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7081810. PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 225674.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A LEAD REPLACEMENT PROCEDURE (MFR. REPORT NO.: 3006630150-2024-03818), THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND DISCOMFORT AT THE POCKET SITE. THE PATIENT UNDERWENT AN SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92379 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7082930 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention