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); Cognitive Changes (2551); No Code Available (3191)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: 1948; exact date of birth is unknown.

Event Description

A report was received that two days after the dbs system was implanted, the patient developed a cerebral hemorrhage, which was moderate in severity.The patient was treated with medication and underwent a computerized tomography (ct) scan.The event was recovered/resolved a week later and the patient was discharged eight days after the onset of the event.The physician assessed the event as having a causal relationship to the procedure and hardware, but not related to stimulation.

Event Description

A report was received that two days after the dbs system was implanted, the patient developed a cerebral hemorrhage, which was moderate in severity.The patient was treated with medication and underwent a computerized tomography (ct) scan.The event was recovered/resolved a week later and the patient was discharged eight days after the onset of the event.The physician assessed the event as having a causal relationship to the procedure and hardware, but not related to stimulation.

Manufacturer Narrative

Additional information was received that the patient developed symptoms of mild bradypsychia and mild left hemiparesia on 16jan2020.The patient was treated with medication and a computed tomography scan (ct) scan showed small signs of hemorrhage suffusion around the tip of the electrode.On (b)(6) 2020, the patient's only clinical signs were left facial weakness.The next day, the patient had no further clinical symptoms and a ct scan showed very small signs of hemorrhage suffusion around the tip of the electrode.The ct scan on 20jan2020 was normal with resolution of the hemorrhage.The physician assessed the event as recovered/resolved on 22jan2020 and the patient was discharged on (b)(6) 2020.

• 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: 9689439
• MDR Text Key: 178571057
• Report Number: 3006630150-2020-00417
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• 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: 03/05/2020

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: 10/14/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5178731
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention