BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 17763607 · Received September 18, 2023

    Report

    Report Number
    3006630150-2023-05615
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    April 5, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2218-50 (SN: (B)(6). THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE PROXIMAL END WAS BENT/FRACTURED BETWEEN CONTACTS 4 AND 5. THE FRACTURED CABLES WERE NOT EXPOSED AND WERE STILL CONTAINED INSIDE THE PROXIMAL ARRAY. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF HIGH IMPEDANCE WAS CONFIRMED. CONTACT 4 OF THE PROXIMAL END OF THE LEAD HAVE FRACTURED CABLE RIGHT AT THE WELD NUGGET. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY.

    Additional Manufacturer Narrative · 0

    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. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5001453/5001325.

    Additional Manufacturer Narrative · 0

    SC-1200, (SN (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED VISUAL INSPECTION AND EXHIBITED NORMAL DEVICE CHARACTERISTICS AND NORMAL IMPEDANCES. DATA LOG ANALYSIS REVEALED THAT THERE WERE CHARGING ISSUES DUE TO THE THERMISTOR BEING TRIGGERED MULTIPLE TIMES. THE IPG WAS ABLE TO BE FULLY CHARGED IN A ROOM TEMPERATURE ENVIRONMENT IN ONE FOUR-HOUR CHARGE CYCLE WITHOUT ANY ANOMALIES. THE CHARGING CURRENT WAS ALSO LOW ON CHARGE CYCLES WHERE THE PATIENT WAS NOT ABLE TO FULLY CHARGE THE IPG. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS CONFIRMED. THE IPG THERMISTOR WAS LIKELY BEING TRIGGERED DUE TO POOR VENTILATION WHILE CHARGING OR POOR CHARGER TO IPG ALIGNMENT WHILE CHARGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD TO CHARGE THE IPG MORE FREQUENTLY. IT WAS ALSO REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD TO CHARGE THE IPG MORE FREQUENTLY. IT WAS ALSO REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD TO CHARGE THE IPG MORE FREQUENTLY. IT WAS ALSO REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269267 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 351157 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention