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 Edema (1820); Hemorrhage, Cerebral (1889); Paralysis (1997); Seizures (2063); Dysphasia (2195)

Event Date 02/14/2020

Event Type  Injury  

Event Description

It was reported that following a dbs lead implant procedure the patient developed edema around the right lead.The patient experienced a seizure and left hemiparesis.The symptoms could be due to the subdural or a combination of edema and an intracerebral hemorrhage.The patient was monitored from an inpatient rehabilitation hospital and then discharged.

Event Description

It was reported that following a dbs lead implant procedure the patient developed edema around the right lead.The patient experienced a seizure and left hemiparesis.The symptoms could be due to the subdural or a combination of edema and an intracerebral hemorrhage.The patient was monitored from an inpatient rehabilitation hospital and then discharged.Additional information was received that the patient experienced two seizures, partial paralysis on the left side, balance and speech issues.The patient chose not to go to therapy due to current corona virus environmental conditions.

• 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: 9812499
• MDR Text Key: 182760815
• Report Number: 3006630150-2020-01091
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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: 01/07/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7071641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR
• Patient Weight: 88