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); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Paralysis (1997); Cognitive Changes (2551)

Event Date 07/23/2022

Event Type  Injury  

Event Description

It was reported that the patient had a deep brain stimulation (dbs) implant procedure and experienced intracranial bleeding and hemiparesis post-operatively.A computerized tomography (ct) scan confirmed subcortical bleeding near the lead site.The physician assessed that the device or procedure contributed to the patients complications.The patient was put in the intensive care unit (icu) for sedation and ventilation while waiting for recovery.

Event Description

It was reported that the patient had a deep brain stimulation (dbs) implant procedure and experienced intracranial bleeding and hemiparesis post-operatively.A computerized tomography (ct) scan confirmed subcortical bleeding near the lead site.The physician assessed that the device or procedure contributed to the patients complications.The patient was put in the intensive care unit (icu) for sedation and ventilation while waiting for recovery.

Manufacturer Narrative

Correction to initial mdr in field h6 patient codes.

Event Description

It was reported that the patient had a deep brain stimulation (dbs) implant procedure and experienced intracranial bleeding which resulted in hemiparesis and reduced cognitive abilities postoperatively.A computerized tomography (ct) scan confirmed subcortical bleeding near the lead site.The physician assessed that the device or procedure contributed to the patients complications.The patient was taken to the intensive care unit (icu) for sedation and ventilation while waiting for recovery.The device remains implanted.Additional information was received that clarified the hemiparesis symptom the patient experienced was paralysis.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15262660
• MDR Text Key: 298278168
• Report Number: 3006630150-2022-04174
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7091846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/07/2022; 10/11/2022
• Supplement Dates FDA Received: 09/15/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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