BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 11627296 · Received April 7, 2021

    Report

    Report Number
    3006630150-2021-01434
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729905196
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB1200S0, MODEL: DB-1200-S, SERIAL: (B)(6), LOT: 737256. PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), LOT: 7010253.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED FALL THAT RESULTED IN A WOUND NEAR THE PATIENT'S NON-BOSTON SCIENTIFIC BURR HOLE COVER. THE PATIENT DEVELOPED AN INFECTION AT THE NON-BOSTON SCIENTIFIC BURR HOLE COVER, LEAD, LEAD EXTENSION AND THE BOSTON SCIENTIFIC M8 LEAD ADAPTER SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHERE THE BOSTON SCIENTIFIC LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC DEVICES WERE REMOVED. DURING THE PROCEDURE, A SWAB WAS TAKEN AT THE BOSTON SCIENTIFIC IPG SITE AND IT WAS ALSO FOUND TO BE POSITIVE FOR AN INFECTION. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE WHERE THE IPG WAS EXPLANTED. THE PATIENT WAS STABLE POST-OPERATIVELY. THE EXPLANTED M8 ADAPTER AND IPG WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICES WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT A SECOND LEAD EXTENSION WAS ALSO EXPLANTED. THE PATIENT WAS HEALING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: (B)(4), MODEL: DB-1200-S, SERIAL: (B)(4), LOT: 737256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED FALL THAT RESULTED IN A WOUND NEAR THE PATIENT'S NON-BOSTON SCIENTIFIC BURR HOLE COVER. THE PATIENT DEVELOPED AN INFECTION AT THE NON-BOSTON SCIENTIFIC BURR HOLE COVER, LEAD, LEAD EXTENSION AND THE BOSTON SCIENTIFIC M8 LEAD ADAPTER SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHERE THE BOSTON SCIENTIFIC LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC DEVICES WERE REMOVED. DURING THE PROCEDURE, A SWAB WAS TAKEN AT THE BOSTON SCIENTIFIC IPG SITE AND IT WAS ALSO FOUND TO BE POSITIVE FOR AN INFECTION. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE WHERE THE IPG WAS EXPLANTED. THE PATIENT WAS STABLE POST-OPERATIVELY. THE EXPLANTED M8 ADAPTER AND IPG WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528091 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-9218-15 7010178 08714729905196

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention