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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced low blood pressure during the deep brain stimulation (dbs) implantable pulse generator (ipg) procedure.X-ray images taken revealed a pneumothorax and hemothorax approximately one liter in volume in the right lung.The physicians assessment noted that he experienced difficulties tunneling subcutaneously crossing of the neck and possibly damaged the blood vessels and parietal pleura.The patient underwent a blood transfusion, a chest tube was placed, was stabilized and placed in intensive care unit (icu).It was noted that the patient is thin, and the physician has only used the boston scientific tunneling tool seven prior times, however, has experience with competitors similar tools.Physical analysis of the dbs tunneler was not performed as it was disposed by the facility.The drain was removed several days later, and the patient is doing well.

• 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: 19378197
• Report Number: 3006630150-2024-03318
• Device Sequence Number: 7689407
• Product Code: MHY
• UDI-Device Identifier: 08714729896104
• UDI-Public: 08714729896104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2025
• Device Model Number: DB-4254
• Device Catalogue Number: DB-4254
• Device Lot Number: 31853809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female