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

Model Number	DB-3128-55B
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Shaking/Tremors (2515); Movement Disorder (4412); Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-ipg-pc, upn: m365db14160, model: db-1416, serial: (b)(6), batch: (b)(6), gtin: (b)(4), udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6) gtin: (b)(4), udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6), gtin: (b)(4), udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was reported to be experiencing a recurrence of tremors, rigidity, and slowness due to impedances and inadequate stimulation.The physician noted that the patient's history of falls may have contributed to these issues.Although reprogramming was attempted, the symptoms persisted.To investigate the cause of the high impedances, the patient underwent exploratory surgery.During the procedure, the sutures securing the implantable pulse generator (ipg) broke, causing the ipg to flip and the lead extension to twist.At this point, the physician decided to revise the lead extension, successfully resolving the impedance issue.Postoperatively, the patient was reported to be doing well.The device was discarded by the medical facility and will not be returned for further analysis.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-ipg-pc.Upn: m365db14160.Model: db-1416.Serial: (b)(6).Batch: (b)(6).Gtin: 08714729985020.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Gtin: 08714729905288.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Gtin: 08714729905288.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was reported to be experiencing a recurrence of tremors, rigidity, and slowness due to impedances and inadequate stimulation.The physician noted that the patients history of falls may have contributed to these issues.Although reprogramming was attempted, the symptoms persisted.To investigate the cause of the high impedances, the patient underwent exploratory surgery.During the procedure, the sutures securing the implantable pulse generator (ipg) broke, causing the ipg to flip and the lead extension to twist.At this point, the physician decided to revise the lead extension, successfully resolving the impedance issue.Postoperatively, the patient was reported to be doing well.The device was discarded by the medical facility and will not be returned for further analysis.Additional information was received that the lead extensions had become tangled, prompting a revision procedure in which new lead extensions were implanted.The ipg was also sutured back into place during the revision.As a result of this issue, the patient experienced a reduction in therapy effectiveness for approximately two months prior to the revision procedure.This event, in conjunction with elevated impedance readings, led to an imaging request that ultimately identified the underlying problem.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device component involved in the event: product family: dbs-ipg-pc, upn: m365db14160, model: db-1416, serial: (b)(6), batch: 230660, gtin: (b)(4), udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7125119, gtin: (b)(4), udi: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7125093, gtin: (b)(4), udi: (b)(4).The devices were not returned for analysis as the lead extension (serial: (b)(6)) and lead (serial: (b)(6)) were discarded and the ipg and lead (serial: (b)(6)) remained implanted and in use; therefore, a technical analysis could not be performed.It was confirmed that all the devices met manufacturing specifications prior to distribution and therefore manufacturing deviations could not have contributed to the reported event.Review of the instructions for use (ifu) confirmed that there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed on the lead extension (serial: (b)(6)) and it confirmed that the event of recurrence of tremors, rigidity, and slowness due to impedances and inadequate stimulation likely caused by falls followed by a reduction in therapy and exploratory surgery were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the production.Based on a thorough revie of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was reported to be experiencing a recurrence of tremors, rigidity, and slowness due to impedances and inadequate stimulation.The physician noted that the patients history of falls may have contributed to these issues.Although reprogramming was attempted, the symptoms persisted.To investigate the cause of the high impedances, the patient underwent exploratory surgery.During the procedure, the sutures securing the implantable pulse generator (ipg) broke, causing the ipg to flip and the lead extension to twist.At this point, the physician decided to revise the lead extension, successfully resolving the impedance issue.Postoperatively, the patient was reported to be doing well.The device was discarded by the medical facility and will not be returned for further analysis.Additional information was received that the lead extensions had become tangled, prompting a revision procedure in which new lead extensions were implanted.The ipg was also sutured back into place during the revision.As a result of this issue, the patient experienced a reduction in therapy effectiveness for approximately two months prior to the revision procedure.This event, in conjunction with elevated impedance readings, led to an imaging request that ultimately identified the underlying problem.

• Brand Name: NA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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: 22287183
• Report Number: 2124215-2025-40377
• Device Sequence Number: 15591289
• Product Code: MHY
• UDI-Device Identifier: 00191506023577
• UDI-Public: (01)00191506023577(17)260422(10)5002836
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 04/22/2026
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5002836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 03/04/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/14/2025; 04/01/2026
• Date Device Manufactured: 04/22/2024
• 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: 76 YR
• Patient Sex: Female