BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA? MRI

    MDR report key: 24323247 · Received February 12, 2026

    Report

    Report Number
    3006630150-2026-00857
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2408-56 (SN (B)(6) AND (B)(6)) / SC-1216 (SN (B)(6)) INVESTIGATION RESULTS, MEDIA REVIEW, DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    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: 7090492, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 810252, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE. WOUND DEHISCENCE AT THE MIDLINE INCISION WAS NOTED. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. DURING THE PROCEDURE, IT WAS ALSO FOUND OUT THAT THE LEADS HAD MIGRATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE. WOUND DEHISCENCE AT THE MIDLINE INCISION WAS NOTED. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. DURING THE PROCEDURE, IT WAS ALSO FOUND OUT THAT THE LEADS HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254810 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7090537 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1