BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 14246151 · Received April 28, 2022

    Report

    Report Number
    3006630150-2022-01898
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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). LOT: 7084508. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55 . SERIAL: (B)(4). LOT: 7093650.

    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), LOT: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55 , SERIAL: (B)(4), LOT: (B)(4). LEAD DB-2202-45 SN (B)(6) WAS NOT RETURNED AS THE DEVICE WAS DISPOSED OF BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. THE RETURNED LEAD DB-2202-45 SN (B)(6) WAS ANALYZED AND REVEALED THAT THE PROXIMAL END OF THE LEAD WAS TORN AFTER CONTACT 7. CONTACT 8 WAS STUCK IN THE ASSOCIATED LEAD EXTENSION AND THE RETENTION SLEEVE WAS NOT RETURNED. CABLES ARE EXPOSED AT THE FRACTURE SITE. IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD DURING THE ATTEMPT TO REMOVE IT FROM THE LEAD EXTENSION AND IT RESULTED IN THE COMPLETE SEPARATION OF THE PROXIMAL END FROM THE LEAD BODY. VISUAL INSPECTION OF PROXIMAL ARRAY CONTACTS 6, 7, AND 8 WERE DEFORMED. IT IS LIKELY THAT THEY WERE DAMAGED BY A SURGICAL TOOL DURING THE IMPLANT PROCEDURE. THE CONTACT DEFORMATION RESULTED IN THE INABILITY TO REMOVE THE LEAD FROM THE LEAD EXTENSION CONNECTOR. THE RETURNED LEAD EXTENSION NM-3138-55 SN (B)(6) WAS ANALYZED AND REVEALED THAT THE ASSOCIATED LEAD WAS STUCK IN THE LEAD EXTENSION CONNECTOR. IT WAS FOUND THAT THE ASSOCIATED LEADS PROXIMAL CONTACTS WERE DEFORMED. THE CONTACT DEFORMATION RESULTED IN THE INABILITY TO REMOVE THE LEAD FROM THE LEAD EXTENSION CONNECTOR. A LABELLING REVIEW WAS PERFORMED DID NOT REVEAL ANY ANOMALIES. THE LABELING, INSTRUCTIONS FOR USE (IFU) STATES THAT DEVICE RELATED RISKS CAN INCLUDE LOSS OF ADEQUATE STIMULATION AND IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR EXTENSION) MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY. POSSIBLE SIDE-EFFECTS OF STIMULATION CAN INCLUDE GAIT DIFFICULTY AND FALLS. THEREFORE, FALLS AND LEAD MIGRATION ARE KNOWN RISKS WITH USE OF THE PRODUCTS. FURTHERMORE, LABELING STATES TO TAKE CARE NOT TO BEND OR KINK THE PROXIMAL LEAD ARRAY, THE STIFF PORTION OF THE LEAD BODY ADJACENT TO THE ARRAY, OR THE LEAD EXTENSION CONNECTOR DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL AND THE LEADS MIGRATED. THE CAUSE OF THE FALL IS UNKNOWN. THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. DURING THE PROCEDURE, ONE LEAD WAS UNABLE TO BE REMOVED FROM THE LEAD EXTENSION, THEREFORE, THE LEAD EXTENSION WAS ALSO REPLACED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL AND THE LEADS MIGRATED. THE CAUSE OF THE FALL IS UNKNOWN. THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. DURING THE PROCEDURE, ONE LEAD WAS UNABLE TO BE REMOVED FROM THE LEAD EXTENSION, THEREFORE, THE LEAD EXTENSION WAS ALSO REPLACED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118659 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7084504 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention