BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10140489 · Received June 10, 2020

    Report

    Report Number
    3006630150-2020-02421
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    November 19, 2019
    Report Date
    August 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: (B)(6). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFECTION AT THE PATIENTS IPG POCKET SITE WAS DISCOVERED DURING A POST-IMPLANT FOLLOW-UP APPOINTMENT. CULTURES WERE TAKEN AND REVEALED THAT THE PATIENT HAD A STAPH INFECTION AT THE IPG POCKET, LEAD AND BURR HOLE SITE. PATIENT THEN HAD A RIGHT PICC LINE PLACED AND UNDERWENT INFUSION THERAPY AND WAS PLACED ON ANTIBIOTICS FOR 4-6 WEEKS. PATIENT UNDERWENT A FULL EXPLANT OF THE DEVICE, AND IS DOING WELL POST-OPERATIVELY; AND HAS SINCE HAD A NEW DEVICE RE-IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED ERYTHEMA AND EDEMA ON THE RIGHT CHEST AT THE LOCATION OF THE IPG POCKET SITE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5120823. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5123230. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT; THEREFORE, THE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION AT THE PATIENTS IPG POCKET SITE WAS DISCOVERED DURING A POST-IMPLANT FOLLOW-UP APPOINTMENT. CULTURES WERE TAKEN AND REVEALED THAT THE PATIENT HAD A STAPH INFECTION AT THE IPG POCKET, LEAD AND BURR HOLE SITE. PATIENT THEN HAD A RIGHT PICC LINE PLACED AND UNDERWENT INFUSION THERAPY AND WAS PLACED ON ANTIBIOTICS FOR 4-6 WEEKS. PATIENT UNDERWENT A FULL EXPLANT OF THE DEVICE, AND IS DOING WELL POST-OPERATIVELY; AND HAS SINCE HAD A NEW DEVICE RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601991 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 739380 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention