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 Bacterial Infection (1735); Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Muscle Weakness (1967); Paralysis (1997)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7102459.Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: null, batch: 30994077.

Event Description

It was reported that the deep brain stimulation (dbs) patient presented with progressive hemiparalysis one sided weakness and an infection which was evident by his elevated esr and crp rates.A computed tomography ct scan was performed.After reviewing the ct image, the physician assessed right sided hygroma or leakage of csf, posterior to the right burr hole.The patient underwent a procedure where the csf fluid was evacuated.There was a follow up ct image performed and revealed that the bleed appeared to be stable.The patient was admitted to the icu to be treated for aspiration pneumonia, leukocytosis, encephalopathy and had an ng tube placed with concerns for bowel issues and remained intubated.The patient was later withdrawn from life support and passed away.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 563384.

Event Description

It was reported that the deep brain stimulation (dbs) patient presented with progressive hemiparalysis one sided weakness and an infection which was evident by his elevated esr and crp rates.A computed tomography ct scan was performed.After reviewing the ct image, the physician assessed right sided hygroma or leakage of csf, posterior to the right burr hole.The patient underwent a procedure where the csf fluid was evacuated.There was a follow up ct image performed and revealed that the bleed appeared to be stable.The patient was admitted to the icu to be treated for aspiration pneumonia, leukocytosis, encephalopathy and had an ng tube placed with concerns for bowel issues and remained intubated.The patient was later withdrawn from life support and passed away.Additional information was received indicating that the physician assessed that the infection was not device related as the patient developed a subdural hematoma.The hematoma impacted the patient's ability to swallow, leading to aspiration pneumonia and subsequent death.Also received the model and serial number for the ipg implanted.

• 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: 17176918
• MDR Text Key: 317630130
• Report Number: 3006630150-2023-03586
• 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: 07/19/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7100917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male