MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Cerebral (1889); Weakness (2145); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 06/16/2020

Event Type  Injury  

Event Description

It was reported that during a permanent implant procedure the patient became confused and experienced weakness on the right side.This occurred after the first lead was successfully implanted in the left hemisphere and the staff was setting up to implant a second lead in the right hemisphere.The time between the lead implant and onset of symptoms was within minutes.The procedure was aborted and the physician noted that an intracranial hemorrhage occurred in the basal ganglia along the left sided planned trajectory.Vasculature was not detected on the magnetic resonance imaging.The physician chose to leave the lead on the left hemisphere implanted as well as the burr hole covers.The event was not a result of device performance.The patient was brought to the intensive care unit and the hemorrhage was evacuated.Three days later the patient returned to surgery due to relieve pressure and symptoms caused by the intracranial hemorrhage.During the same surgery the physician explanted the left hemisphere lead.The patient was released from the hospital with what could turn out to be a permanent tracheostomy as he is not able to breath on his own.The patient does not have a good prognosis.The explanted devices were discarded and will not be returned.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10268290
• MDR Text Key: 198697777
• Report Number: 3006630150-2020-02892
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7073985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR