BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS¿

    MDR report key: 12676388 · Received October 21, 2021

    Report

    Report Number
    3006630150-2021-05910
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    May 1, 2021
    Report Date
    November 5, 2021
    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)(6). BATCH: 7085239. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7083758.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AFTER THE STAGE 2 DEEP BRAIN STIMULATION (DBS) PROCEDURE. THE PHYSICIAN ASSESSED THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG WAS REMOVED, AND MADE A FULL-RECOVERY POST-OPERATIVELY. THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; AND THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED INDICATED TWO LEAD EXTENSIONS WERE ALSO REMOVED DURING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    EVENT DATE: EXACT DATE IS UNKNOWN, EVENT OCCURRED BETWEEN (B)(6) 2021 AND (B)(6) 2021. EXPLANT DATE: EXACT DATE IS UNKNOWN, EXPLANT OCCURRED APPROXIMATELY ONE MONTH AFTER IMPLANTABLE PULSE GENERATOR WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AFTER THE STAGE 2 DEEP BRAIN STIMULATION (DBS) PROCEDURE. THE PHYSICIAN ASSESSED THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG WAS REMOVED, AND MADE A FULL-RECOVERY POST-OPERATIVELY. THE DEVICE WAS DISPOSED OF BY THE HOSPITAL; AND THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569576 VERCISE GENUS¿ STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 506325 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention