BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10304713 · Received July 21, 2020

    Report

    Report Number
    3006630150-2020-03022
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 29, 2020
    Report Date
    March 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7071066 / 7071088.

    Additional Manufacturer Narrative · 0

    SC-1200, (SN: (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TEST PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2408-56, (SN: (B)(6)). SC-2408-56, (SN: (B)(6)). THE RETURNED LEADS WERE ANALYZED AND IT WAS REVEALED THAT THE VISUAL INSPECTION OF THE LEADS WERE CLEANLY CUT. NO ANOMALIES WERE IDENTIFIED ON THE LEADS ASIDE FROM THE CLEAN-CUT. THE DAMAGE TO THE LEADS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS ALSO NOTED THAT THE PATIENT SUSTAINED A FALL AND HAD THE POCKET SITE INJURED WHICH CAUSED THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS ALSO NOTED THAT THE PATIENT SUSTAINED A FALL AND HAD THE POCKET SITE INJURED WHICH CAUSED THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LINEAR LEADS-MRI :UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7071066 / 7071088.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS ALSO NOTED THAT THE PATIENT SUSTAINED A FALL AND HAD THE POCKET SITE INJURED WHICH CAUSED THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766565 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 367850 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention