BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 10358401 · Received August 3, 2020

    Report

    Report Number
    3006630150-2020-03208
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND UNDESIRED SENSATIONS WHEN THE DEVICE WAS TURNED OFF. THE PHYSICIAN CONFIRMED WITH THE BOSTON SCIENTIFIC REPRESENTATIVE THAT THE PATIENTS LEAD WAS NON-FUNCTIONAL AND THE LEAD WAS LIKELY FRACTURED GIVEN THAT IT HAS NOT MOVED BY RECENT X-RAY. THE PATIENT WILL UNDERGO A LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISPOSED.

    Additional Manufacturer Narrative · 1

    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: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 20940414.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND UNDESIRED SENSATIONS WHEN THE DEVICE WAS TURNED OFF. THE PHYSICIAN CONFIRMED WITH THE BOSTON SCIENTIFIC REPRESENTATIVE THAT THE PATIENTS LEAD WAS NON-FUNCTIONAL AND THE LEAD WAS LIKELY FRACTURED GIVEN THAT IT HAS NOT MOVED BY RECENT X-RAY. THE PATIENT WILL UNDERGO A LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822103 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 20276929 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention