BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 18667156 · Received February 8, 2024

    Report

    Report Number
    3006630150-2024-00542
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    April 10, 2023
    Report Date
    February 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7071059. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12000. MODEL: SC-1200. SERIAL: (B)(6). BATCH: 369447.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS NOT RECEIVED ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING. LEAD MIGRATION WAS CONFIRMED WITH FLUOROSCOPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED, AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781505 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 7070971 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention