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 Muscle Weakness (1967); Cognitive Changes (2551); Confusion/ Disorientation (2553); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/22/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 7098585.

Event Description

It was reported that the deep brain stimulation (dbs) patient started to exhibit confusion and cognitive issues four days post bilateral lead implant.The post-operative ct scan showed no signs of anything out of the ordinary.The patient was admitted to the hospital.Another ct scan was performed and showed some edema around the lead, only in the left hemisphere, with possible worsening.The patient was experiencing confusion, expressive aphasia and some right sided weakness.The patient received a lumbar puncture which showed no sign of infection.The edema was non-enhancing as well, which also suggests the lack of infection according to neurology.There were no signs of bleeding or hemorrhage per radiology and neurology.The patient was discharged to an inpatient rehab facility and is being treated aggressively with steroids.The patient has been receiving periodical scans showing edema was marginally better.

Event Description

It was reported that the deep brain stimulation (dbs) patient started to exhibit confusion and cognitive issues four days post bilateral lead implant.The post-operative ct scan showed no signs of anything out of the ordinary.The patient was admitted to the hospital.Another ct scan was performed and showed some edema around the lead, only in the left hemisphere, with possible worsening.The patient was experiencing confusion, expressive aphasia and some right sided weakness.The patient received a lumbar puncture which showed no sign of infection.The edema was non-enhancing as well, which also suggests the lack of infection according to neurology.There were no signs of bleeding or hemorrhage per radiology and neurology.The patient was discharged to an inpatient rehab facility and is being treated aggressively with steroids.The patient has been receiving periodical scans showing edema was marginally better.Additional information was received indicating the most recent scan showed 75 percent reduction in edema.The patient's speech is improving and also improving from a strength perspective.Patient will soon be seen for re-programming.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6).

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16396276
• MDR Text Key: 309772592
• Report Number: 3006630150-2023-00657
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7098449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female