BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12067940 · Received June 25, 2021

    Report

    Report Number
    3006630150-2021-03214
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: (B)(4). MODEL: SC-2408-74 SERIAL: (B)(4). BATCH: 7072171. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: (B)(4). MODEL: SC-2408-74 SERIAL: (B)(4). BATCH: 7072140.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS MOST LIKELY NOT DEVICE RELATED AND THAT NOTHING HAPPENED DURING THE SCS IMPLANT PROCEDURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962386 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 373842 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R