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

Model Number	DB-4254
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's skin was punctured in several places at the neck area while using the tunneling tool during an implant procedure of the deep brain stimulation (dbs) system.The skin punctures were sutured, and the procedure was completed with a non-boston scientific tunneling tool.The patient did well postoperatively.The physician stated that the device was difficult to use, however it was discarded by the facility and not returned for analysis.

• Brand Name: NA
• Common Device Name: 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16762959
• Report Number: 3006630150-2023-02093
• Device Sequence Number: 3037521
• Product Code: MHY
• UDI-Device Identifier: 08714729896104
• UDI-Public: 08714729896104
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2024
• Device Model Number: DB-4254
• Device Catalogue Number: DB-4254
• Device Lot Number: 29705192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male