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

Model Number DB-2202-45

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Shaking/Tremors (2515); Speech Disorder (4415)

Event Date 04/27/2022

Event Type  Injury  

Event Description

It was reported that high impedances were noted on the patients deep brain stimulation (dbs) lead causing inadequate therapy and the patients parkinsons symptoms of tremors in the right hand, head and vocal to return.Computerized tomography scan (ct scan) was performed, and no fractures were identified and confirmed the placement of the device.The patient underwent a revision procedure in which the lead, lead extension and burr hole cover were replaced and is doing well post operatively.Physical analysis of the dbs lead, lead extension and burr-hole cover was not performed as they were retained by the facility.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension: upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7060335.Product family: dbs-lead fixation: upn: m365db4600c0.Model: db-4600c.Serial: n/a.Batch: 24068724.

• 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: 17738210
• MDR Text Key: 323303974
• Report Number: 3006630150-2023-05531
• 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: 09/13/2023

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 Expiration Date: 09/05/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5172931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• 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: 54 YR
• Patient Sex: Female