BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 8140112 · Received December 6, 2018

    Report

    Report Number
    3006630150-2018-62133
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS REPLACED DUE TO THE PATIENT RECEIVING AN EARLY REPLACEMENT INDICATOR.THIS SUPPLEMENTAL CORRECTION REPORT IS BEING FILED TO CORRECT THE REPORT NUMBER IN A PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT (FOLLOW-UP NUMBER 001) WHICH WAS ACCEPTED BY FDA ON 12/13/2018 04:56 PM CT.THE REPORT NUMBER IS BEING CORRECTED FROM: 3006630150-2018-62270TO: 3006630150-2018-62133.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY INSERTING THE EXTENSION INTO THE PORT OF THE NEW IPG. AFTER THE PHYSICIAN RE-INSERTED THE EXTENSION, HE NOTICED THAT THE SCREW WAS TILTED AND IT WAS FIXED IN THE SILICONE SEAL. IN ORDER TO REACH THE SCREW AGAIN, THE PHYSICIAN HAD TO CUT A LITTLE BIT OF THE SILICONE SEAL. THE PHYSICIAN NOTED THAT ONE CONTACT EXTENSION WAS DAMAGED AFTER ALL THE TRIALS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: N/I, SERIAL/LOT: N/I, DESCRIPTION: UNKNOWN SCS LEAD EXTENSION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY INSERTING THE EXTENSION INTO THE PORT OF THE NEW IPG. AFTER THE PHYSICIAN RE-INSERTED THE EXTENSION, HE NOTICED THAT THE SCREW WAS TILTED AND IT WAS FIXED IN THE SILICONE SEAL. IN ORDER TO REACH THE SCREW AGAIN, THE PHYSICIAN HAD TO CUT A LITTLE BIT OF THE SILICONE SEAL. THE PHYSICIAN NOTED THAT ONE CONTACT EXTENSION WAS DAMAGED AFTER ALL THE TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979767 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1140 18318163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention