MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NM-3138-55

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Discomfort (2330)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a feeling of tension in her neck.The physician assessed the lead extensions had become tethered due to scar tissue.The patient underwent a procedure to release the scar tissue, a second procedure to revise the lead extensions, and a third procedure to reposition the implantable pulse generator (ipg) higher and suture down.The patient did well postoperatively.Physical analysis of the lead extensions could not be conducted in our laboratory, as the devices were cut during the procedure and discarded by the facility; and the ipg remains implanted in the patient.

Manufacturer Narrative

Block b3: exact date unknown, event occurred in november 2023 additional suspect medical device component involved in the event: product family: dbs-extension upn: m365nm3138550 model: nm-3138-55 serial: (b)(6).Batch: 7082023 product family: dbs-ipg-r-mri upn: m365db12000 model: db-1200 serial: (b)(6).Batch: 746536.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 18727621
• MDR Text Key: 335700946
• Report Number: 3006630150-2024-00766
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/16/2024

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: 11/19/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7082084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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 Sex: Female