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

Model Number DB-2202-30

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

Patient Problems Stroke/CVA (1770); Hemorrhage, Cerebral (1889); High Blood Pressure/ Hypertension (1908); Confusion/ Disorientation (2553)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-30, serial: unknown, batch: unknown.

Event Description

It was reported that the patient experienced a stroke post implant of two leads for a trial period of the deep brain stimulation system.While in the recovery the patient developed confusion, high blood pressure.A scan was taken which confirmed the bleed in the area of the right thalamus.The patient was transferred back to the operating room at which time the external section of the leads, which were left externalized to connect to be connected at a later procedure, were cut to remove the external section and leaving the section of the leads implanted in the brain still implanted.The physician reported that he believes that the cause of the event was the initial insertion of the micro drive insertion cannula and before the lead was implanted.The patient is recovering and improving.The cut external sections of the leads were discarded by the facility and not returned for analysis.The serial number of the devices was not provided.

Event Description

It was reported that the patient experienced a stroke post implant of two leads for a trial period of the deep brain stimulation system.While in the recovery the patient developed confusion, high blood pressure.A scan was taken which confirmed the bleed in the area of the right thalamus.The patient was transferred back to the operating room at which time the external section of the leads, which were left externalized to connect to be connected at a later procedure, were cut to remove the external section and leaving the section of the leads implanted in the brain still implanted.The physician reported that he believes that the cause of the event was the initial insertion of the micro drive insertion cannula and before the lead was implanted.The patient is recovering and improving.The cut external sections of the leads were discarded by the facility and not returned for analysis.The serial number of the devices was not provided.

• 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
• MDR Report Key: 10492385
• MDR Text Key: 205671853
• Report Number: 3006630150-2020-03923
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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 Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR