BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11590864 · Received March 30, 2021

    Report

    Report Number
    3006630150-2021-01294
    Event Type
    Injury
    Date Received
    March 30, 2021
    Date of Event
    March 1, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE RETURNED IPG WAS ANALYZED AND A REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT AS A RESULT OF FAULTY INSULATION. A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.THEREFORE, A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND FELT THE AFFECTED AREA WAS SWOLLEN AND PAINFUL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, PLACED ON ANTIBIOTICS AND WAS DOING WELL AFTER THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK BEFORE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7071444. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4316, BATCH: 26012374.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND FELT THE AFFECTED AREA WAS SWOLLEN AND PAINFUL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, PLACED ON ANTIBIOTICS AND WAS DOING WELL AFTER THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485228 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 372259 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention