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); Laceration(s) (1946); Weight Changes (2607)

Event Date 08/17/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced a cut around the deep brain stimulation (dbs) left lead extension site.It was noted the patient has lost weight with loose skin and was unaware they accidently cut themselves and did not experience any symptoms per the patients response.Infection was noted the patient underwent a procedure where the wound was closed per the physicians assessment, however date of procedure and if cultures were taken are unknown.The patient was administered intravenous (iv) anti-biotics and prescribed oral anti-biotics from aug2023 until jan2024 under the care of their physician.The patient experienced a reoccurrence of the infection ten day after the prescribed anti-biotics were completed.The patient had a procedure where they removed the entire dbs system to allow infection to heal properly per the physicians assessment.Physical analysis of the dbs devices were not performed as they were retained by the facility.The patient did well post-operatively.

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: 514665.Product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45 serial: (b)(6).Batch: 7082983 product family: dbs-extension upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7089384.Product family: dbs-extension upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7089121 product family: dbs-lead fixation upn: m365db4600c0.Model: db-4600c.Serial: n/a batch: 26656772.Product family: dbs-lead fixation upn: m365db4600c0.Model: db-4600c.Serial: n/a batch: 26612853.

• 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: 18692323
• MDR Text Key: 335191501
• Report Number: 3006630150-2024-00632
• Device Sequence Number: 1
• Product Code: NHL
• 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
• Report Date: 02/12/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7082963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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 Age: 75 YR
• Patient Sex: Male