BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 20276480 · Received September 23, 2024

    Report

    Report Number
    3006630150-2024-06356
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT:18849063. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7072554.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT CHANGED FIELDS B5 AND H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7072554.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) KIT FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO LEADS HAD MIGRATED TO THE PATIENT'S NECK AS IN THE FIRST SURGERY, SURGEON DID NOT SUTURE THE LEAD CONNECTION DOWN, IT ALSO SHOWN HIGH IMPEDANCES ON LEADS. HIGH IMPEDANCE WAS NOT FIXED BECAUSE THE SURGEON CONCLUDED THE LEAD NEEDS TO BE FIXED AND THAT IS A DIFFERENT SURGERY. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784713 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741350 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention