BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11931374 · Received June 3, 2021

    Report

    Report Number
    3006630150-2021-02652
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 6, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1200 (SN: (B)(6)) THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2408-56 (SN: (B)(6)) THE RETURNED LEAD WAS ANALYZED AND VISUAL AND X-RAY INSPECTIONS CONFIRMED 2 CABLES (E2, E3) ARE FRACTURED AT THE CLICK SITE, ABOUT 27 CENTIMETERS FROM THE DISTAL END. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT WHEN EXCESSIVE MECHANICAL/TENSILE FORCE WAS EXERTED ONTO THE LEAD, THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE CABLE FRACTURES. THE PROBABLE CAUSE SELECTED FOR THIS LEAD FRACTURE WAS CAUSE TRACED TO COMPONENT FAILURE, HOWEVER, IT WAS UNKNOWN IF THE SAID SYMPTOMS WERE DEVICE RELATED. THEREFORE, THIS INVESTIGATION WAS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE COULD NOT BE ESTABLISHED. SC-2408-56 (SN: (B)(6)) THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-4319 (BATCH 26729931) THE RETURNED CLIK ANCHOR WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASED HEART RATE, CHILLS, SWEATING IN HANDS AND PAIN IN THE RIBS EVEN WITH THE STIMULATOR TUNED OFF. IT WAS UNKNOWN IF THE SAID SYMPTOMS WERE DEVICE RELATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7073049 / 7073042 . PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, SERIAL: N/A, BATCH: 26729931.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASED HEART RATE, CHILLS, SWEATING IN HANDS AND PAIN IN THE RIBS EVEN WITH THE STIMULATOR TUNED OFF. IT WAS UNKNOWN IF THE SAID SYMPTOMS WERE DEVICE RELATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825358 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 375149 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention