BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12608351 · Received October 11, 2021

    Report

    Report Number
    3006630150-2021-05680
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 11, 2021
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7071158. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, SERIAL: N/A, BATCH: 26210250.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND REDNESS AROUND THE WOUNDS AND HAD TROUBLE WALKING. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE ENTIRE SPINAL CORD STIMULATOR (SCS) SYSTEM DUE TO AN INFECTION AT THE IPG SITE AND LAMINECTOMY SITE. IT IS UNKNOWN WHAT SPECIFICALLY CAUSED THE INFECTION, HOWEVER, THE INFECTION OCCURRED POST IMPLANTATION. THE PATIENT WAS TREATED WITH CLOXACILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501289 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 370978 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention