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 Edema (1820); Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Seizures (2063); Shaking/Tremors (2515); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Date of birth: (b)(6): exact date is unknown.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200, serial: (b)(4), batch: 736752.Product family: dbs-linear leads: upn: (b)(4), model: db-2202-30, serial: (b)(4), batch: 5079520.A review of the manufacturing documentation for the two leads and the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.

Event Description

A report was received that the patient, that is enrolled in the (b)(6) clinical study, developed post-operative bleeding around the left electrode which was moderate in severity.A computed tomography scan confirmed bleeding from the puncture passage left frontal and suspected bleeding from the puncture passage right frontal.It was then observed that the patient developed postoperative bleeding subcortically around the right electrode which was moderate in severity.A second computed tomography scan taken several days later showed increasing edema with constant bleeding on the left electrode and no bleeding of the puncture passage on the right with perifocal edema.The patient then experienced a focal epileptic seizure which was moderate in severity.The patient underwent rehabilitation treatment to address the bleeding, was treated with medication to address the epileptic seizure, and his admission was prolonged, and was subsequently discharged.The bleeding was assessed as having a causal relationship to the procedure and possible relationship to the device.The seizure was assess as having a probable relationship to the procedure and possible relationship to the hardware.The event has resolved, and the patient recovered.

Manufacturer Narrative

Additional information was received that the patient developed a tremor in the right leg, aphasia, episodes of mental confusion, noticeable slowdown, fluctuating orientation with delirium and apathy.

Event Description

A report was received that the patient, that is enrolled in the vercise dbs registry clinical study, developed post-operative bleeding around the left electrode which was moderate in severity.A computed tomography scan confirmed bleeding from the puncture passage left frontal and suspected bleeding from the puncture passage right frontal.It was then observed that the patient developed postoperative bleeding subcortically around the right electrode which was moderate in severity.A second computed tomography scan taken several days later showed increasing edema with constant bleeding on the left electrode and no bleeding of the puncture passage on the right with perifocal edema.The patient then experienced a focal epilectic seizure which was moderate in severity.The patient underwent rehabilitation treatment to address the bleeding, was treated with medication to address the epilectic seizure, and his admission was prolonged, and was subsequently discharged.The bleeding was assessed as having a causal relationship to the procedure and possible relationship to the device.The seizure was assess as having a probable relationship to the procedure and possible relationship to the hardware.The event has resolved, and the patient recovered.

• 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: 8506366
• MDR Text Key: 141725376
• Report Number: 3006630150-2019-01638
• 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
• Report Date: 09/05/2019

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: 05/25/2020
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5055338
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention