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

Model Number	DB-2201-45-DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Meningitis (2389)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in march 2023.
Event or Problem Description
It was reported that a computed tomography (ct) scan taken in the field revealed a cloudy white area, described as halation, around the right lead of the patients deep brain stimulation (dbs) system.The condition was monitored for one month, but the halation did not subside.The cause of the halation was unknown, but the physician assessed the patient to likely have mild meningitis, and the patient underwent a procedure where the dbs lead was removed as a precaution.Cultures were taken but the results were not provided.Physical analysis of the dbs lead was not performed as it was retained by the facility.
Event or Problem Description
It was reported that a computed tomography (ct) scan taken in the field revealed a cloudy white area, described as halation, around the right lead of the patients deep brain stimulation (dbs) system.The condition was monitored for one month, but the halation did not subside.The cause of the halation was unknown, but the physician assessed the patient to likely have mild meningitis, and the patient underwent a procedure where the dbs lead was removed as a precaution.Cultures were taken but the results were not provided.Physical analysis of the dbs lead was not performed as it was retained by the facility.Additional information was received that the patients dbs burr-hole cover was also removed during this procedure.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 30218441.

• 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; 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: 16908313
• Report Number: 3006630150-2023-02642
• Device Sequence Number: 5562103
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/12/2023
• Device Model Number: DB-2201-45-DC
• Device Catalogue Number: DB-2201-45-DC
• Device Lot Number: 7071660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/21/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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 Sex: Male