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

Model Number DB-2202-30

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a lead repositioning procedure due to lead migration.The patient experienced inadequate therapy as a result of the lead migration.The patient was doing well postoperatively.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a lead repositioning procedure due to lead migration.The patient experienced a reduction in symptom relief as a result of the lead migration.The patient was doing well postoperatively.

• 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: 18307527
• MDR Text Key: 330223202
• Report Number: 3006630150-2023-07773
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/08/2024

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: 07/14/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7074983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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