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 Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7108945; product family: upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7115395; product family: upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7115395; product family: upn: m365db12160, model: db-1216, serial: (b)(6), batch: 566768 ; product family: upn: m365db46000, model: db-4600, serial: n/a, batch: 31754641; product family: upn: m365db46000, model: db-4600, serial: n/a, batch: 32076167.

Event Description

It was reported that the patient experienced redness and swelling around the deep brain stimulation (dbs) scalp incision site.It was noted that there was infection, and that the device did not cause the event per the physician assessments, however cultures were not taken to confirm presence of infection.The patient underwent a procedure where the dbs entire system was removed per the physicians preference.Physical analysis of the dbs devices was not performed as they were retained by the facility.The patient was prescribed anti-biotics and did well post-operatively.

• 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: 19155284
• MDR Text Key: 340793004
• Report Number: 3006630150-2024-02518
• 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
• Report Date: 04/22/2024

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7108986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: White