BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 10891362 · Received November 24, 2020

    Report

    Report Number
    3006630150-2020-05729
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 9, 2020
    Report Date
    May 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCKS; B1: SHOULD HAVE ONLY STATED ADVERSE EVENT. H6: SHOULD HAVE HAD BLOCK H6 PATIENT CODE 3191: NO CODE AVAILABLE. BLOCK H6 PATIENT CODE 3191: NO CODE AVAILABLE WAS USED AS THERE IS NO EQUIVALENT FDA CODE FOR ADDITIONAL INTERVENTION.

    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), LOT: 7073540. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), LOT: 7077181. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), LOT: 7077182. PRODUCT FAMILY: DBS-IPG, UPN: M365DB12000, MODEL: DB-1200, SERIAL: (B)(6), LOT: 742711.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA A DAY AFTER A DBS LEAD IMPLANT PROCEDURE, PRIOR TO BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS ADMINISTERED CORTISONE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT. THE PHYSICIAN SUSPECTED THE EVENT MAY BE DUE TO A REACTION TO THE LEAD MATERIAL. ADDITIONAL INFORMATION WAS RECEIVED THAT 14 DAYS POST-IMPLANT, THE SUBJECT EXPERIENCED A SERIOUS PERI-LEAD EDEMATOUS REACTION WITH PSYCHIATRIC COMPLICATIONS INCLUDING SEVERE CONFUSION. A CONTINUOUS TOMOGRAPHY SCAN OF THE HEAD SHOWED HYPODENSE WHITE MATTER CHANGES AROUND THE PUNCTURE CHANNEL ON BOTH SIDES, MORE ON THE LEFT THAN RIGHT SIDE. THE PATIENT WAS GIVEN MEDICATION AND REPEAT CT EXAMS WERE PERFORMED. THE HOSPITALIZATION WAS PROLONGED, HOWEVER, THE EVENT IS RESOLVING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO DEVELOPED PSYCHIATRIC COMPLICATIONS OF APATHY, NEUROCOGNITIVE IMPAIRMENT, AND TEMPORARY PSYCHOSIS WITH HALLUCINATIONS DUE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA A DAY AFTER A DBS LEAD IMPLANT PROCEDURE, PRIOR TO BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS ADMINISTERED CORTISONE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT. THE PHYSICIAN SUSPECTED THE EVENT MAY BE DUE TO A REACTION TO THE LEAD MATERIAL. ADDITIONAL INFORMATION WAS RECEIVED THAT 14 DAYS POST-IMPLANT, THE PATIENT EXPERIENCED A SERIOUS PERI-LEAD EDEMATOUS REACTION WITH PSYCHIATRIC COMPLICATIONS WHICH INCLUDED SEVERE CONFUSION. A CONTINUOUS TOMOGRAPHY SCAN OF THE HEAD SHOWED HYPODENSE WHITE MATTER CHANGES AROUND THE PUNCTURE CHANNEL ON BOTH SIDES, MORE ON THE LEFT THAN RIGHT SIDE. THE PATIENT WAS GIVEN MEDICATION AND REPEAT CT EXAMS WERE PERFORMED. THE HOSPITALIZATION WAS PROLONGED, HOWEVER, THE EVENT IS RESOLVING. THE PHYSICIAN ASSESSED THIS EVENT TO HAVE A PROBABLE RELATIONSHIP TO THE PROCEDURE, POSSIBLY RELATED TO DEVICE STIMULATION, AND NOT RELATED TO DEVICE HARDWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA A DAY AFTER A DBS LEAD IMPLANT PROCEDURE, PRIOR TO BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS ADMINISTERED CORTISONE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT. THE PHYSICIAN SUSPECTED THE EVENT MAY BE DUE TO A REACTION TO THE LEAD MATERIAL. ADDITIONAL INFORMATION WAS RECEIVED THAT 14 DAYS POST-IMPLANT, THE SUBJECT EXPERIENCED A SERIOUS PERI-LEAD EDEMATOUS REACTION WITH PSYCHIATRIC COMPLICATIONS INCLUDING SEVERE CONFUSION. A CONTINUOUS TOMOGRAPHY SCAN OF THE HEAD SHOWED HYPODENSE WHITE MATTER CHANGES AROUND THE PUNCTURE CHANNEL ON BOTH SIDES, MORE ON THE LEFT THAN RIGHT SIDE. THE PATIENT WAS GIVEN MEDICATION AND REPEAT CT EXAMS WERE PERFORMED. THE HOSPITALIZATION WAS PROLONGED, HOWEVER, THE EVENT IS RESOLVING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO DEVELOPED PSYCHIATRIC COMPLICATIONS OF APATHY, NEUROCOGNITIVE IMPAIRMENT, AND TEMPORARY PSYCHOSIS WITH HALLUCINATIONS DUE TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE EDEMA STILL EXISTS AND THE PATIENT IS DISABLED DUE TO THE EDEMA. THE PATIENT REQUIRES A FULL-TIME NURSE AND PHYSIOTHERAPY. NO FURTHER COURSE OF ACTION IS ANTICIPATED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL : DB-2202-45, SERIAL : (B)(4), LOT: 7073540.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA A DAY AFTER A DBS LEAD IMPLANT PROCEDURE, PRIOR TO BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS ADMINISTERED CORTISONE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT. THE PHYSICIAN SUSPECTED THE EVENT MAY BE DUE TO A REACTION TO THE LEAD MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361433 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7071266 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R| O