BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20024647 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05380
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    November 22, 2023
    Report Date
    August 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED CLOSE TO THE STAGE TWO PROCEDURE ON 22NOV2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7112838. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7120697.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A PULLING SENSATION IN THEIR CHEST. THE PHYSICIAN INITIALLY ASSESSED THE LIKELY CAUSE OF THE SENSATION WAS THE RESULT OF THE IMPLANTABLE PULSE GENERATOR (IPG) HAVING MIGRATED DOWNWARD. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE IPG WHEREIN BOWSTRINGING OF THE LEAD EXTENSIONS IN THE NECK WERE OBSERVED. IT WAS REVEALED THAT A SUTURE HAD BEEN INCORRECTLY WRAPPED AROUND THE LEAD EXTENSION BY THE PHYSICIAN DURING THE IMPLANT PROCEDURE WHICH RESULTED IN THE BOWSTRINGING OF THE LEAD EXTENSION AND PULLING OF THE IPG. ONCE THAT STITCH WAS CUT, THE IPG RESTED WELL IN THE POCKET; AND THE PATIENT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397499 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 584485 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention