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 Hematoma (1884); Dysphasia (2195); Insufficient Information (4580)

Event Date 03/14/2021

Event Type  Death  

Event Description

It was reported that the patient had a hematoma in the frontal lobe of the right hemisphere of their brain.The patient seemed confused and had a hard time finding words to communicate.The patient also had a blood disease, polycythemia vera, which gives a slightly increased risk of blood clots, and discreet parkinsons symptoms.Anticoagulation treatment was resumed after the first acute ct scan and infection rates showed no issues.The patient later experienced cramps in their left extremities, but it quickly subsided once they were given stesolid medication intramuscularly.Later that morning, the patient was found with pupil difference, snoring respiration, and was uncontactable.The patient had a second acute ct scan performed, which showed a very large amount of bleeding in relation to the lead in the right hemisphere.The physician noted that there was a breakthrough into the ventricular system and there were no neurosurgical treatment options.The patient was transferred to the icu before passing away.The official cause of death is large bleeding in relation to the lead in the frontal lobe of the right hemisphere with a breakthrough into the ventricular system.The complication occurred after a permanent implant procedure and prior to discharge.The leads will not be explanted.

• 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; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11645576
• MDR Text Key: 244786108
• Report Number: 3006630150-2021-01342
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2021

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: 12/13/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7078784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2020
• 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): Death