BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 13146284 · Received January 3, 2022

    Report

    Report Number
    3006630150-2021-07431
    Event Type
    Injury
    Date Received
    January 3, 2022
    Date of Event
    October 20, 2021
    Report Date
    January 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7070066 AND 7070322.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6) AND (B)(6); BATCH: 7070066 AND 7070322.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSING HIS PREEXISTING SYMPTOMS TO RETURN. SEVERAL REPROGRAMMING SESSIONS OF THE DEVICE SYSTEM WERE MADE BUT WERE NOT SUCCESSFUL. THE DEVICE DATABASE WAS ANALYZED, AND NO ANOMALIES WERE NOTED. THE PATIENT UNDERWENT AN IPG, IMPLANTABLE PULSE GENERATOR, AND LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR DEVICE ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSING HIS PREEXISTING SYMPTOMS TO RETURN. SEVERAL REPROGRAMMING SESSIONS OF THE DEVICE SYSTEM WERE MADE BUT WERE NOT SUCCESSFUL. THE DEVICE DATABASE WAS ANALYZED, AND NO ANOMALIES WERE NOTED. THE PATIENT UNDERWENT AN IPG, IMPLANTABLE PULSE GENERATOR, AND LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR DEVICE ANALYSIS AS THEY WERE RETAINED BY THE FACILITY. A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED, AND NO ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96449 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1140-S 631570 08714729984467

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention