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); Erosion (1750); Dysphasia (2195); Meningitis (2389); Confusion/ Disorientation (2553)

Event Date 04/14/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation dbs lead eroded through the patients front right side of the scalp.The patient experienced delirium and an aphasic event.The patient went to the emergency room and was hospitalized.The physician assessed the patient had meningitis due to a (b)(6) infection around the eroded lead.The patient was administered levetiracetam, oxacillin, cefepime, acetaminophen and heparin and underwent a dbs system explant procedure.The patient was less delirious the following day, however, not back at the baseline.The patient was discharged from the hospital and admitted to a subacute rehabilitation facility and will continue intravenous antibiotics through may.The event was assessed as severe and causally related to the lead.The explanted devices were retained by the medical facility.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); lot: (b)(4).Product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); lot: (b)(4).Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); lot: (b)(4).Product family: dbs-ipg-pc; upn: m365db1140s0; model: db-1140-s; serial: (b)(4); lot: (b)(4).

Event Description

It was reported that the deep brain stimulation dbs lead eroded through the patients front right side of the scalp.The clinical study patient experienced delirium and an aphasic event.The patient went to the emergency room and was hospitalized.The physician assessed the patient had meningitis due to a staphylococcus aureus infection around the lead erosion.The patient was administered levetiracetam, oxacillin, cefepime, acetaminophen and heparin and underwent a dbs system explant procedure.The patient was less delirious the following day however, not back at the baseline.The patient was discharged from the hospital and admitted to a subacute rehabilitation facility and will continue intravenous antibiotics through may.The event was assessed as causally related to the lead.The explanted devices were retained by the medical facility.

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), lot: 7087274.Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: 7081857.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7087167.Product family: dbs-ipg-pc, upn: m365db1140s0, model: db-1140-s, serial: (b)(6), lot: 633403.Product family: dbs-lead fixation (2 sets), upn: m36db1140c0, model: db1140-c, serial: n/a, lot: 27123412.Correction to the initial mdr in block b5 and g2.The returned lead db-2202-45, sn: (b)(6) was analyzed and found the tip of the distal end was fractured, this damage likely occurred during the explant procedure when the lead was forcefully pulled out from the port.This damage is not considered a source for the reported complaint.The returned lead db-2202-45, sn: (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.The returned lead extension nm-3138-55, sn: (b)(6) was analyzed and found to be cleanly cut after the distal boot.The damage is a result of a typical explant procedure and is not considered a source for the reported complaint.Lead db-2202-45, sn: (b)(6) was not returned as it was disposed of by the medical facility.Analysis of additional devices is pending completion.A labelling review was performed for the devices and it did not reveal any anomalies.The instructions for use states that confusion, problems with attention, thinking, or memory, infection, brain or cerebral spinal fluid (csf) fluid infection, inflammation and speech or language difficulties are known risks with use of the devices.Additionally, implanted device components such as the stimulator, lead or lead extension, may move from the original implanted location or wear through the skin, which may lead to the need for additional surgery.As such, engineers have assessed that the reported events are known risks with use of the devices.

Event Description

It was reported that the deep brain stimulation dbs lead eroded through the patients front right side of the scalp.The clinical study patient experienced delirium and an aphasic event.The patient went to the emergency room and was hospitalized.The physician assessed the patient had meningitis due to a staphylococcus aureus infection around the lead erosion.The patient was administered levetiracetam, oxacillin, cefepime, acetaminophen and heparin and underwent a dbs system explant procedure.The patient was less delirious the following day however, not back at the baseline.The patient was discharged from the hospital and admitted to a subacute rehabilitation facility and will continue intravenous antibiotics through may.The event was assessed as causally related to the lead.The explanted devices were retained by the medical facility.

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), lot: 7087274.Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: 7081857.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7087167.Product family: dbs-ipg-pc, upn: m365db1140s0, model: db-1140-s, serial: (b)(6), lot: 633403.Product family: dbs-lead fixation (2 sets), upn: m36db1140c0, model: db1140-c, serial: n/a, lot: 27123412.The returned lead db-2202-45, sn: (b)(6) was analyzed and found the tip of the distal end was fractured, this damage likely occurred during the explant procedure when the lead was forcefully pulled out from the port.This damage is not considered a source for the reported complaint.The returned lead db-2202-45, sn: (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.The returned lead extension nm-3138-55, sn: (b)(6) was analyzed and found to be cleanly cut after the distal boot.The damage is a result of a typical explant procedure and is not considered a source for the reported complaint.A labelling review was performed for all these devices and they did not reveal any anomalies.The instructions for use states that confusion, problems with attention, thinking, or memory, infection, brain or cerebral spinal fluid (csf) fluid infection, inflammation and speech or language difficulties are known risks with use of the devices.Additionally, implanted device components such as the stimulator, lead or lead extension, may move from the original implanted location or wear through the skin, which may lead to the need for additional surgery.As such, engineers have assessed that the reported events are known risks with use of the devices.The returned lead db-2202-45 sn: (b)(6) was analyzed and found to be cleanly cut during the explant procedure and the distal end was not returned.The damage is a result of a typical explant procedure, and it is not considered a source for the reported complaint.The returned ipg db-1140-s, sn: (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.Analysis of these two devices did not reveal any additional information.

Manufacturer Narrative

Correction to the initial mdr: lead model number: db-2202-45, sn: (b)(6) should have been lead extension model nm-3138-55, sn: (b)(6).Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7087274.Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: 7081857.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7087167.Product family: dbs-ipg-pc, upn: m365db1140s0, model: db-1140-s, serial: (b)(6), lot: 633403.Product family: dbs-lead fixation (2 sets), upn: m36db1140c0, model: db1140-c, serial: n/a, lot: 27123412.The returned lead db-2202-45 sn: (b)(6) was analyzed and found the tip of the distal end was fractured, this damage likely occurred during the explant procedure when the lead was forcefully pulled out from the port.This damage is not considered a source for the reported complaint.The returned lead db-2202-45 sn: (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.The returned lead extension nm-3138-55, sn: (b)(6) was analyzed and found to be cleanly cut after the distal boot.The damage is a result of a typical explant procedure and is not considered a source for the reported complaint.A labelling review was performed for all these devices and they did not reveal any anomalies.The instructions for use states that confusion, problems with attention, thinking, or memory, infection, brain or cerebral spinal fluid (csf) fluid infection, inflammation and speech or language difficulties are known risks with use of the devices.Additionally, implanted device components such as the stimulator, lead or lead extension, may move from the original implanted location or wear through the skin, which may lead to the need for additional surgery.As such, engineers have assessed that the reported events are known risks with use of the devices.-the returned lead nm-3138-55 sn: (b)(6) was analyzed and found to be cleanly cut during the explant procedure and the distal end was not returned.The damage is a result of a typical explant procedure, and it is not considered a source for the reported complaint.-the returned ipg db-1140-s, sn: (b)(6) was analyzed, passed all tests performed, and exhibited normal device characteristics.Analysis of these two devices did not reveal any additional information.

Event Description

It was reported that the deep brain stimulation dbs lead eroded through the patients front right side of the scalp.The clinical study patient experienced delirium and an aphasic event.The patient went to the emergency room and was hospitalized.The physician assessed the patient had meningitis due to a staphylococcus aureus infection around the lead erosion.The patient was administered levetiracetam, oxacillin, cefepime, acetaminophen and heparin and underwent a dbs system explant procedure.The patient was less delirious the following day however, not back at the baseline.The patient was discharged from the hospital and admitted to a subacute rehabilitation facility and will continue intravenous antibiotics through may.The event was assessed as causally related to the lead.The explanted devices were retained by the medical facility.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14350800
• MDR Text Key: 291356985
• Report Number: 3006630150-2022-02157
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/02/2022

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 Expiration Date: 05/04/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7081839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 06/30/2022; 08/02/2022; 08/16/2022
• Supplement Dates FDA Received: 07/29/2022; 08/09/2022; 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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; Other; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female