BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 11750931 · Received April 29, 2021

    Report

    Report Number
    3006630150-2021-01858
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: 7031617.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD EXTENSION THAT WAS PROTRUDING THROUGH HER SCALP AND THERE WAS AN ACTUAL BREAK IN THE SKIN. THE PHYSICIAN ELECTED TO REPLACE BOTH LEAD EXTENSIONS DUE TO POSSIBLE RISK OF INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND BOTH LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. THE PATIENT WAS FULLY RECOVERED AND DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646538 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 21291083 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention