BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 10043870 · Received May 11, 2020

    Report

    Report Number
    3006630150-2020-02030
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    March 1, 2020
    Report Date
    May 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2408-56, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5033786, MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE ADJUSTED FOR AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506342 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 5033775 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention