BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11610638 · Received April 2, 2021

    Report

    Report Number
    3006630150-2021-01373
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    February 17, 2020
    Report Date
    April 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT EVENT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7070675/5155154.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED SENSATION AROUND THE IMPLANT AREA AND AROUND THE HIP WHICH WAS DESCRIBED TO BE TENDER. IT WAS ALSO STATED THAT THE PATIENT FELT BLOATED WHILE STIMULATION WAS ON AND THAT THE PATIENT WAS HAVING INVOLUNTARY URINATION AND CONSTIPATION. THE PHYSICIAN ASSESSED THAT THE ISSUE STEMMED FROM POSITION OF IMPLANTS AND THAT PATIENT IS TOO THIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND THE IPG WAS REPLACED. THE PATIENT HAD EXCELLENT COVERAGE WITHOUT SIDE EFFECTS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505972 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365597 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention