BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 11750949 · Received April 29, 2021

    Report

    Report Number
    3006630150-2021-01860
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 22, 2021
    Report Date
    June 4, 2021
    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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE WOUNDS HAS NOT CLOSED AND THE SCREW IS VISIBLE. IT IS UNKNOWN WHICH OF THE TWO THAT THE PATIENT IS IMPLANTED WITH IS INVOLVED WITH THE EVENT. THE PHYSICIAN PLANS ON DOING A SURGICAL REVISION AT A FUTURE DATE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN PERFORMED A SURGICAL PROCEDURE WHERE THE EXTENSION WAS MOVED CLOSE, AND THE WOUND WAS SUTURED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550 , MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7070335.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE WOUNDS HAS NOT CLOSED AND THE SCREW IS VISIBLE. IT IS UNKNOWN WHICH OF THE TWO THAT THE PATIENT IS IMPLANTED WITH IS INVOLVED WITH THE EVENT. THE PHYSICIAN PLANS ON DOING A SURGICAL REVISION AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646596 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7070163 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R