BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 10791110 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05354
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: (B)(4), MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7015779. THE DEVICES WERE NOT RETURNED TO BOSTON SCIENTIFIC CORPORATION BSC FOR ANALYSIS. HOWEVER, PHOTOS TAKEN DURING THE PROCEDURE WERE SENT TO BSC AND THE COMPLAINT OF LEAD DAMAGE FOR LEAD SC-2408-74 HAS BEEN CONFIRMED. INSPECTION OF THE PHOTO REVEALED THAT THE LEAD WAS PULLED UNTIL LEAD INSULATION WAS DAMAGED RIGHT AT THE PROXIMAL ARRAY RETENTION SLEEVE. DUE TO THE INSULATION DAMAGE, THE COILED CABLES WERE UNWOUND AND STRETCHED. IT APPEARS THAT EXCESSIVE TENSILE FORCE WAS EXERTED ONTO THE LEAD BODY WHEN THE LEAD WAS PULLED TO REPOSITION, CAUSING THE LEAD DAMAGE. THEREFORE, THE PROBABLE CAUSE OF THE BROKEN LEAD IS DUE TO UNINTENDED USE ERROR. PER THE PHOTO RECEIVED FOR THE LEAD EXTENSION SC-3138-25, NO ANOMALIES WERE IDENTIFIED ON THE FLUOROSCOPY PHOTO OF THE LEAD EXTENSION. THE ALLEGATION OF LEAD AND LEAD EXTENSION MIGRATION HAS BEEN CONFIRMED BASED ON THE PHYSICIANS OBSERVATION DURING THE PROCEDURE. IFU STATES THAT ONE OF THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE LEAD MIGRATION. THEREFORE, THE PROBABLE CAUSE OF MIGRATION IS A KNOWN INHERENT RISK OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SECOND STAGE PROCEDURE TO IMPLANT THE SCS IPG, THE PHYSICIAN NOTED THAT THE ALREADY IMPLANTED LEAD AND LEAD EXTENSION HAD MIGRATED TO THE PATIENTS SIDE. THE PHYSICIAN PULLED ON THE LEAD EXTENSION TO RECOVER THE DEVICES AND WHEN PULLED, THE LEAD WAS HEARD TO HAVE SNAPPED. FLUOROSCOPY WAS TAKEN AND DISPLAYED THAT THE LEAD WAS CLEARLY BROKEN WHERE IT CONNECTED TO THE LEAD EXTENSION. THE PHYSICIAN OPENED THE PATIENTS SIDE, DISCONNECTED THE BROKEN LEAD FROM THE LEAD EXTENSION AND EXPLANTED THE DEVICES. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261583 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 7071027 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention