BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10448255 · Received August 25, 2020

    Report

    Report Number
    3006630150-2020-03621
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND WILL UNDERGO FUTURE EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NON DEVICE RELATED INFECTION WAS LOCATED AT THE IPG POCKET SITE INCISION. SYMPTOMS INCLUDE DRAINAGE, NON CLOSURE, AND PAIN AT POCKET SITE. THE PATIENT WAS INITIALLY PLACED ON IV ANTIBIOTICS, THEN SWITCHED TO ORAL ANTIBIOTICS. CULTURES WERE TAKEN AND THE RESULT REVEALED STAPHYLOCOCCUS AUREUS AND OXACILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (OSSA). THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND PADDLE LEAD WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: (B)(4), MODEL: SC-8416-70, SERIAL: (B)(4), BATCH: 7013078.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND WILL UNDERGO SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915258 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 361396 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention