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

Model Number DB-2202-45

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported that the patient's deep brain stimulation (dbs) leads tethered at their neck site, which was confirmed through imaging.The patient also experienced irritation, soreness, and redness on their scalp at the lead and lead extension connector site as the leads had eroded through the skin.The patient underwent a system explant procedure and was doing well postoperatively.The devices were retained by the medical facility and will not be returned for analysis.

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: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial:(b)(6), lot: (b)(6).

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: 7098525; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7108985; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7109099; product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, lot: 30357431.

Event Description

It was reported that the patients deep brain stimulation (dbs) leads tethered at their neck site, which was confirmed through imaging.The patient also experienced irritation, soreness, and redness on their scalp at the lead and lead extension connector site as the leads had eroded through the skin.The patient underwent a system explant procedure and was doing well postoperatively.The devices were retained by the medical facility and will not be returned for analysis.

• 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 sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17971288
• MDR Text Key: 326119939
• Report Number: 3006630150-2023-06393
• 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,Followup
• Report Date: 11/09/2023

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7098525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: 66 YR
• Patient Sex: Female