BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA? MRI

    MDR report key: 21372881 · Received February 13, 2025

    Report

    Report Number
    3006630150-2025-00679
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 21, 2025
    Report Date
    May 20, 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
    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: 7083822. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 755167.

    Additional Manufacturer Narrative · 0

    SC-2408-56 (SN: (B)(6)). THE EXPLANTED LEADS WERE ANALYZED AND VISUAL INSPECTION REVEALED THAT THE LEADS WERE CLEANLY CUT INTO TWO PIECES APPROXIMATELY 35 CM AND 32 CM FROM THE DISTAL END OF THE LEADS. THE ELECTRICAL TEST COULD NOT BE PERFORMED DUE TO THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEADS. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM THE AS REPORTED OBSERVATIONS WITH TESTING OF THE PRODUCT RETURN. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. HOWEVER, A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. SC-1216 (SN: (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF WITH THE PERCUTANEOUS LEADS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD FOR MORE STIMULATION COVERAGE OF THE PAIN AREAS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED TO ACCOMMODATE THE PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF WITH THE PERCUTANEOUS LEADS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD FOR MORE STIMULATION COVERAGE OF THE PAIN AREAS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED TO ACCOMMODATE THE PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582610 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7083525 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1