BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 18356999 · Received December 19, 2023

    Report

    Report Number
    3006630150-2023-07944
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 5, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7081477.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT A JOLT IN LEFT LEG AND HAD A HEADACHE. XRAY REVEALED THAT ONE LEAD PULLED OUT OF EPIDURAL SPACE. THE PHYSICIAN ALSO NOTED SUPERFICIAL SEROMA. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE LEADS REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152232 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7081408 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention