BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11030343 · Received December 17, 2020

    Report

    Report Number
    3006630150-2020-06249
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 27, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON 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-2138-50, SERIAL: (B)(4), BATCH: 141900. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4), MODEL: SC-2138-70, SERIAL: (B)(4), BATCH: 138669/142047.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LACERATION ON THE IPG SITE DUE TO A NON DEVICE RELATED FALL. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490103 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 2000021982 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention