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 Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient with significant brain atrophy and a difficult surgical trajectory underwent a revision procedure to have a new dbs system implanted.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient with significant brain atrophy and a difficult surgical trajectory underwent a revision procedure to have a new dbs system implanted.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads; upn: unk-p-dbs-linear_leads; model: unknown; serial: unknown; batch: unknown.Product family: dbs-ipg-r; upn: unk-p-dbs-ipg-r; model: unknown; serial: unknown; batch: unknown.

• 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: 18432976
• Report Number: 3006630150-2023-08316
• Device Sequence Number: 20591558
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2022
• Device Model Number: DB-2201-45-DC
• Device Catalogue Number: DB-2201-45-DC
• Device Lot Number: 7070904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White