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); Dysphagia/ Odynophagia (1815); Muscle Weakness (1967); Visual Disturbances (2140); Speech Disorder (4415)

Event Date 06/15/2021

Event Type  Injury  

Event Description

It was reported that the patient suffered a stroke, which was life-threatening, and was treated with medication.The physician assessed the event as recovering/resolving and possibly related to procedure and hardware, but not related to stimulation.

Event Description

It was reported that the patient suffered a stroke, which was life-threatening.The patient was treated with medication.The physician assessed as recovering/resolving and possibly related to procedure and hardware, but not related to stimulation.Additional information was received that the patient developed symptoms of right sided hemiparesis, homonymous hemianopia, and dysarthria.A head computed tomography scan (ct) showed evidence of ischemic stroke in the region of the left basal ganglia in proximity to the left lead implant.The patient was unable to swallow and therefore a nasogastric tube was placed to facilitate feeding and administration of parkinsons disease medications.The physician assessed the event as having a possible relationship to the procedure, but not related to hardware and stimulation.The event is recovering/resolving.

Manufacturer Narrative

Field a2 date of birth: 1958; exact date of birth is unknown.

Event Description

It was reported that the patient suffered a stroke, which was life-threatening.The patient was treated with medication.The physician assessed as recovering/resolving and possibly related to procedure and hardware, but not related to stimulation.Additional information was received that the patient developed symptoms of right sided hemiparesis, homonymous hemianopia, and dysarthria.A head computed tomography scan (ct) showed evidence of ischemic stroke in the region of the left basal ganglia in proximity to the left lead implant.The patient was unable to swallow and therefore a nasogastric tube was placed to facilitate feeding and administration of parkinsons disease medications.The physician assessed the event as having a possible relationship to the procedure, but not related to hardware and stimulation.The event is recovering/resolving.

• 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: 12298503
• MDR Text Key: 265763117
• Report Number: 3006630150-2021-04338
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• 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,Followup
• Report Date: 10/05/2021

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: 04/25/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7074234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 09/09/2021
• Supplement Dates FDA Received: 09/09/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention