BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS¿

    MDR report key: 13972437 · Received April 1, 2022

    Report

    Report Number
    3006630150-2022-01373
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    September 14, 2021
    Report Date
    March 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 7084237. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550 , MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7085390. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0 , MODEL: DB-4600C, SERIAL: N/A, BATCH: 26729878. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0 , MODEL: DB-4600C, SERIAL: N/A, BATCH: 26793896. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4605C0, MODEL: DB-4605C, SERIAL: N/A, BATCH: 26515106. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7080528. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7080583.

    Additional Manufacturer Narrative · 0

    DB-1216, (B)(6) THE RETURNED IPG PASSED THE VISUAL INSPECTION AND REVEALED NO ANOMALIES. DB-2202-45, (B)(6) VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES FROM THE DISTAL END OF THE LEAD. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY BREATHING AND A FLUCTUATION IN HER BLOOD PRESSURE AND HEART RATE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY BREATHING AND A FLUCTUATION IN HER BLOOD PRESSURE AND HEART RATE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN ASSESSED HE DOES NOT THINK THIS ISSUE WAS DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY BREATHING AND A FLUCTUATION IN HER BLOOD PRESSURE AND HEART RATE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN ASSESSED HE DOES NOT THINK THIS ISSUE WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731080 VERCISE GENUS¿ STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 506347 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention