BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 8030928 · Received November 1, 2018

    Report

    Report Number
    3006630150-2018-61622
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 1, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820758
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-9818-15, SERIAL/LOT: (B)(4), DESCRIPTION: VERCISE M8 ADAPTER 15CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE IPG SITE. THE IPG AND M8 ADAPTORS WERE EXPLANTED. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE OR PROCEDURE RELATED BUT COULD NOT IDENTIFY THE CAUSE OF THE INFECTION. THE PATIENT WAS PROVIDED WITH ANTIBIOTICS AND WAS STABLE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870404 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1110C 21164459 08714729820758

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention