BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 18175475 · Received November 20, 2023

    Report

    Report Number
    3006630150-2023-07193
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 26, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7101056. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093057.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7101056. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093057.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INFLAMMATION AND EDEMA. THE PHYSICIAN NOTED EXPOSURE OF THE LEAD AND LEAD EXTENSION CONNECTION. THE PATIENT UNDERWENT A WOUND WASHOUT, DEBRIDEMENT AND RELOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMINISTERED CLINDAMYCIN AND WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INFLAMMATION AND EDEMA. THE PHYSICIAN NOTED EXPOSURE OF THE LEAD AND LEAD EXTENSION CONNECTION. THE PATIENT UNDERWENT A WOUND WASHOUT, DEBRIDEMENT AND RELOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMINISTERED CLINDAMYCIN AND WAS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN ADDITIONAL WOUND WASH AS THE EXTENSION WAS RE-EXPOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INFLAMMATION AND EDEMA. THE PHYSICIAN NOTED EXPOSURE OF THE LEAD AND LEAD EXTENSION CONNECTION. THE PATIENT UNDERWENT A WOUND WASHOUT, DEBRIDEMENT AND RELOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719819 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 748157

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention