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

Model Number	DB-2201-45-DC
Medical Device Problem Codes	High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-extension, upn: m365db312895b0, model: db-3128-95b, serial: (b)(6), batch: 5000181.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate dystonia coverage.Impedances were observed and two surgeries were performed to identify the source of the impedances.The physician initially replaced the lead but the impedances remained, so a second revision was performed to replace the lead extension.The patient was doing well post-operatively.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-extension, upn: m365db312895b0, model: db-3128-95b, serial: (b)(6), batch: 5000181.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate dystonia coverage.Impedances were observed and two surgeries were performed to identify the source of the impedances.The physician initially replaced the lead but the impedances remained, so a second revision was performed to replace the lead extension.The patient was doing well post-operatively.Additional information received indicates that the explanted lead was discarded by the facility.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate dystonia coverage.Impedances were observed and two surgeries were performed to identify the source of the impedances.The physician initially replaced the lead but the impedances remained, so a second revision was performed to replace the lead extension.The patient was doing well post-operatively.Additional information received indicates that the explanted lead was discarded by the facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365db312895b0.Model: db-3128-95b.Serial: (b)(6).Batch: 5000181.Analysis of returned lead extension, db-3128-95b (5000181), consisted of a visual (microscope) and x-ray inspection of the lead extension which revealed that three cables are completely broken at the bent kinked section close to the proximal end, near the vent port.No cables are exposed at this portion of the lead extension.The lead extension anomaly resulted in the reported complaint.However, although the potential cause of the observed impedance has been identified, the nature of how the proximal tail body or the cables within the body fractured is unknown.Further investigation is required to assess the root cause, thus cause not established.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18647228
• Report Number: 3006630150-2024-00492
• Device Sequence Number: 8200807
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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: Lay User/Patient
• Device Expiration Date: 11/15/2019
• Device Model Number: DB-2201-45-DC
• Device Catalogue Number: DB-2201-45-DC
• Device Lot Number: 21387922
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/16/2024; 09/26/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/19/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White