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 Bacterial Infection (1735); Erosion (1750)

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient visited the emergency room as they were experiencing soreness, fluid draining and blood behind the right ear at the incision site.The physician assessed there was an infection and erosion at the site of the extension connection.The patient underwent a revision procedure where the extension was removed, and antibiotics were administered.The patient was expected to fully recover post-operatively.

Event Description

It was reported that the deep brain stimulation (dbs) patient visited the emergency room as they were experiencing soreness, fluid draining and blood behind the right ear at the incision site.The physician assessed there was an infection and erosion at the site of the extension connection.The patient underwent a revision procedure where the extension was removed, and antibiotics were administered.The patient was expected to fully recover post-operatively.Additional information was received indicating that the physician recently met with the patient for a follow up visit as he was planning on removing the lead but assessed that the incision looked good, and cultures returned with no growth and were negative for infection.He opened the incision and removed the lead boot and ticked the lead away from the incision site and vancomycin medication was administered.The patient was doing well post procedure.

• Brand Name: NA
• 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: 15809771
• MDR Text Key: 303795695
• Report Number: 3006630150-2022-06293
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7098977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female