BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 19461657 · Received June 4, 2024

    Report

    Report Number
    3006630150-2024-03596
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    June 27, 2023
    Report Date
    August 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2408-56 (SN:(B)(6)) THE RETURNED SPINAL CORD STIMULATION (SCS) LEAD WAS ANALYZED, AND X-RAY INSPECTION SHOWED TWO BROKEN CABLES RIGHT AT THE BURNED SECTION OF THE LEAD BODY. THE LEAD BODY WAS MOST LIKELY EXPOSED TO THE USE OF ELECTROCAUTERY DURING THE REPORTED NON-DEVICE RELATED SURGERY. THE EXPOSURE TO ELECTROCAUTERY CAUSED DAMAGE TO THE LEAD BODY AND FRACTURED TWO OF THE INTERNAL CABLES. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ALLEGATION OF HIGH IMPEDANCE HAS BEEN CONFIRMED. THE PROBABLE CAUSE SELECTED IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    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: 7071340.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS SUSPECTED TO BE FRACTURE DURING A NON DEVICE RELATED PROCEDURE. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS SUSPECTED TO BE FRACTURED DURING A NON DEVICE RELATED PROCEDURE. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609006 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7071334

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention