MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problems Fracture (1260); Unexpected Therapeutic Results (1631)

Patient Problems Unspecified Infection (1930); Movement Disorder (4412)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient will undergo a lead revision procedure to address a possible infection or lead fracture.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the intervention provided, product information, confirmation of lead fracture and or infection, patient outcome, and device return outcome.

Event Description

It was reported that the deep brain stimulation (dbs) patient will undergo a lead revision procedure to address a possible infection or lead fracture.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the intervention provided, product information, confirmation of lead fracture and or infection, patient outcome, and device return outcome.Additional information was received indicating the reason for the lead replacement was due to poor positioning of the lead wherein it was no longer proving sufficient therapy to address the patients symptoms.It was also indicted that there was no presence of a lead fracture or infection.

Event Description

It was reported that the deep brain stimulation (dbs) patient will undergo a lead revision procedure to address a possible infection or lead fracture.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the intervention provided, product information, confirmation of lead fracture and or infection, patient outcome, and device return outcome.Additional information was received indicating the reason for the lead replacement was due to poor positioning of the lead wherein it was no longer proving sufficient therapy to address the patients symptoms.It was also indicted that there was no presence of a lead fracture or infection.Additional information was received indicating the patient was doing well post-operatively and symptoms have improved.The date of the lead replacement procedure was also provided.

Event Description

It was reported that the deep brain stimulation (dbs) patient will undergo a lead revision procedure to address a possible infection or lead fracture.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the intervention provided, product information, confirmation of lead fracture and or infection, patient outcome, and device return outcome.Additional information was received indicating the reason for the lead replacement was due to poor positioning of the lead wherein it was no longer proving sufficient therapy to address the patients symptoms.It was also indicted that there was no presence of a lead fracture or infection.Additional information was received indicating the patient was doing well post-operatively and symptoms have improved.The date of the lead replacement procedure was also provided.Additional information was received indicating that the explanted lead was discarded at the facility and was not returned to bsc.

• 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: 18162078
• MDR Text Key: 328425762
• Report Number: 3006630150-2023-07138
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2024

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: 08/20/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7085230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 12/26/2023; 01/29/2024
• Supplement Dates FDA Received: 12/26/2023; 01/24/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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
• Patient Sex: Female