BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 14598918 · Received June 3, 2022

    Report

    Report Number
    3006630150-2022-02690
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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)(4); BATCH: 21169236. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202300; MODEL: DB-2202-30; SERIAL: (B)(4); BATCH: 20984731. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: 3143070 BATCH: 20359324.

    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: 21169236. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 20984731. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 20359324. THE LEAD EXTENSIONS WERE RETURNED AND ANALYZED: MODEL: NM-3138-55; SERIAL: (B)(6) X-RAY INSPECTION OF THE LEAD EXTENSION REVEALED ELECTRODE 8 WAS FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY AND CONNECTOR SECTION OF THE LEAD. BENDING THE DISTAL END COULD ALSO CAUSE CABLE FRACTURES IN THE CONNECTOR SECTION OF THE LEAD. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE CONNECTOR. MODEL: NM-3138-55; SERIAL: (B)(6) X-RAY INSPECTION OF THE LEAD EXTENSION REVEALED ALL ELECTRODES WERE FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY AND CONNECTOR SECTION OF THE LEAD. BENDING THE DISTAL END COULD ALSO CAUSE CABLE FRACTURES IN THE CONNECTOR SECTION OF THE LEAD. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE CONNECTOR. A LABELING REVIEW WAS PERFORMED ON THE LEAD EXTENSIONS INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE LEAD EXTENSIONS WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE IDENTIFIED ON THE LEFT SIDE LEAD, AND AS THE NUMBER OF IMPEDANCES INCREASED IT WAS SUSPECTED THAT THERE WERE FRACTURES ON BOTH THE LEFT AND RIGHT SIDE LEADS. DURING THE EXPLANT PROCEDURE THE LEADS WERE DEEMED TO BE INTACT. THE HIGH IMPEDANCES WERE CONFIRMED TO BE ON THE LEFT AND RIGHT SIDE LEAD EXTENSIONS. BOTH LEADS AND LEAD EXTENSIONS WERE REPLACED DURING THE PROCEDURE, AND THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE IDENTIFIED ON THE LEFT SIDE LEAD, AND AS THE NUMBER OF IMPEDANCES INCREASED IT WAS SUSPECTED THAT THERE WERE FRACTURES ON BOTH THE LEFT AND RIGHT SIDE LEADS. DURING THE EXPLANT PROCEDURE THE LEADS WERE DEEMED TO BE INTACT. THE HIGH IMPEDANCES WERE CONFIRMED TO BE ON THE LEFT AND RIGHT SIDE LEAD EXTENSIONS. BOTH LEADS AND LEAD EXTENSIONS WERE REPLACED DURING THE PROCEDURE, AND THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335167 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 21140810 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention