BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 15392221 · Received September 9, 2022

    Report

    Report Number
    3006630150-2022-04649
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    October 28, 2020
    Report Date
    November 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 7076450. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 7076603. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). BATCH: 7093916.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6) . BATCH: 7076450. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7076603. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093916. CORRECTION TO THE INITIAL MDR IN FIELD B5. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE FACILITY. ANALYSIS OF THE RETURNED IPG INDICATED THAT THE IPG PASSED ALL TESTS PERFORMED. HOWEVER, THE DEVICE EXHIBITED AN ELECTROCAUTERY BURN MARK ON THE FRONT FACE OF THE CASE. THE DAMAGE RESULTED FROM THE EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, THE IFU STATES THAT WORSENING OF DISEASE SYMPTOMS, POTENTIALLY CAUSED BY LOSS OF STIMULATION, MEDICATION CHANGES, SURGERY OR ILLNESS ARE KNOWN RISKS WITH THE USE OF DBS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DEEP BRAIN STIMULATION (DBS) PATIENT THAT TWO DAYS AFTER THE IMPLANT PROCEDURE THE TREMOR RETURNED AND WAS WORSE. THE PATIENT EXPLAINED THAT THE WHEN THE STIMULATION WAS TURNED ON THE TREMOR WAS BETTER THAN WHEN THE STIMULATION WAS TURNED OFF. THE PATIENT COULD NO LONGER FEED HERSELF, GO TO THE BATHROOM INDEPENDENTLY, SHE WAS LIVING IN AN ASSISTED LIVING HOME AND WAS DEPRESSED. THE PHYSICIAN ATTEMPTED REPROGRAMMING TWICE A WEEK FOR A YEAR BUT THE ISSUE REMAINED. THE PHYSICIAN DID NOT BELIEVE THE DEVICE OR PROCEDURE CONTRIBUTED TO THE WORSENING OF THE TREMOR BUT RATHER IT WAS A RESULT OF THE PROGRESSION OF THE PATIENT'S CONDITION. THE PHYSICIAN REVISED THE PATIENT EVEN THOUGH THERE WAS A SMALL CHANCE OF IMPROVEMENT. AFTER THE REVISION PROCEDURE, THE LEFT REPLACEMENT LEAD WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT) TO BE OFF TARGET SO THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM (OR), LATER THAT EVENING, AND A NEW LEAD WAS PLACED IN THE TARGET LOCATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DEEP BRAIN STIMULATION (DBS) PATIENT THAT TWO DAYS AFTER THE IMPLANT PROCEDURE THE TREMOR RETURNED AND WAS WORSE. THE PATIENT EXPLAINED THAT THE WHEN THE STIMULATION WAS TURNED ON THE TREMOR WAS BETTER THAN WHEN THE STIMULATION WAS TURNED OFF. THE PATIENT COULD NO LONGER FEED HERSELF, GO TO THE BATHROOM INDEPENDENTLY, SHE WAS LIVING IN AN ASSISTED LIVING HOME AND WAS DEPRESSED. THE PHYSICIAN ATTEMPTED REPROGRAMMING TWICE A WEEK FOR A YEAR BUT THE ISSUE REMAINED. THE PHYSICIAN DID NOT BELIEVE THE DEVICE OR PROCEDURE CONTRIBUTED TO THE WORSENING OF THE TREMOR BUT RATHER IT WAS A RESULT OF THE PROGRESSION OF THE PATIENT'S CONDITION. THE PHYSICIAN REVISED THE PATIENT EVEN THOUGH THERE WAS A SMALL CHANCE OF IMPROVEMENT. AFTER THE REVISION PROCEDURE, THE LEFT REPLACEMENT LEAD WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT) TO BE OFF TARGET SO THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM (OR), LATER THAT EVENING, AND A NEW LEAD WAS PLACED IN THE TARGET LOCATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819717 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 744209 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention