BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17243606 · Received June 30, 2023

    Report

    Report Number
    3006630150-2023-03825
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    May 18, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED DB-3128-55B SERIAL NUMBER (B)(6) REVEALED THE LEAD EXTENSION BODY WAS SEVERELY TWISTED AND COILED. X-RAY IMAGES OF THE DEVICE CONFIRMED MULTIPLE CABLES WERE FRACTURED. THIS SUGGESTS THAT THE IMPLANTABLE PULSE GENERATOR (IPG) ROTATED MULTIPLE TIMES IN THE POCKET RESULTING IN DEFORMATION OF THE LEAD EXTENSION. ADDITIONALLY, VISUAL INSPECTION REVEALED THE LEAD EXTENSION WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 52 CENTIMETERS FROM THE PROXIMAL END OF THE LEAD. THE CLEAN-CUT DAMAGE IS THE RESULT OF A TYPICAL EXPLANT PROCEDURE, AND THEREFORE, IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312855B0. MODEL: DB-3128-55B. SERIAL: (B)(6). BATCH: 5000398.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WHILE SLEEPING, AND THE FEELING OF THERAPY ABRUPTLY TURNING ON. THE PATIENT NOTED SHE TURNS A LOT IN HER SLEEP AND FELT THAT THE IPG FLIPPED SEVERAL TIMES SINCE BEING IMPLANTED. THE PHYSICIAN ASSESSED THE PRESENCE OF HIGH IMPEDANCE MEASUREMENTS, AND THE PATIENT UNDERWENT AN EXPLORATORY SURGERY TO DETERMINE THE CAUSE. DURING THE PROCEDURE X-RAY IMAGING WAS DONE AND CONFIRMED THE IPG HAD FLIPPED SEVERAL TIMES IN THE POCKET, AND THE PHYSICIAN REPLACED THE EXTENSION AND SECURED THE IPG IN PLACE. THE PATIENT DID WELL POSTOPERATIVELY AND RECEIVED ADEQUATE THERAPY. THE EXPLANTED EXTENSION WAS RETAINED BY THE FACILITY; THEREFORE, PHYSICAL ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WHILE SLEEPING, AND THE FEELING OF THERAPY ABRUPTLY TURNING ON. THE PATIENT NOTED SHE TURNS A LOT IN HER SLEEP AND FELT THAT THE IPG FLIPPED SEVERAL TIMES SINCE BEING IMPLANTED. THE PHYSICIAN ASSESSED THE PRESENCE OF HIGH IMPEDANCE MEASUREMENTS, AND THE PATIENT UNDERWENT AN EXPLORATORY SURGERY TO DETERMINE THE CAUSE. DURING THE PROCEDURE X-RAY IMAGING WAS DONE AND CONFIRMED THE IPG HAD FLIPPED SEVERAL TIMES IN THE POCKET, AND THE PHYSICIAN REPLACED THE EXTENSION AND SECURED THE IPG IN PLACE. THE PATIENT DID WELL POSTOPERATIVELY AND RECEIVED ADEQUATE THERAPY. THE EXPLANTED EXTENSION WAS RETAINED BY THE FACILITY; THEREFORE, PHYSICAL ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19250 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 215336 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention