BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 10048190 · Received May 12, 2020

    Report

    Report Number
    3006630150-2020-02041
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION: UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7070335.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO HIS PHYSICIAN WITH WOUND DEHISCENCE AT THE SITE WHERE THE EXTENSIONS WERE IMPLANTED. THE PHYSICIAN PERFORMED A REVISION WHEREIN THE WOUND WAS RESHAPED. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511832 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7070163 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention