BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 20103593 · Received August 29, 2024

    Report

    Report Number
    3006630150-2024-05764
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: M365SC2408740, MODEL: SC-2408-74, SERIAL#: (B)(6), LOT#: 7078100, PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL#: (B)(6), LOT#: 7072233. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL#: (B)(6), LOT#: 5150626. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL#: (B)(6), LOT#: 750350.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE SPINAL CORD STIMULATION LEAD IMPLANT PUNCTURE SITE ON THE BACK OF THE PATIENT WAS INFECTED. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315485 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7071268

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention