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

Model Number	NM-3138-55
Medical Device Problem Codes	High impedance (1291); Nonstandard Device (1420); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Fall (1848); Shaking/Tremors (2515)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximation - the patient fell out of bed and hit their head on the nightstand about 3 to 4 weeks prior to the aware date.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7119298 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7119409 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure due to high impedances.The patient had fallen out of bed and struck their head on the nightstand, related to rapid eye movement (rem) sleep behavior disorder secondary to parkinson's disease.The fall was determined not to be related to the dbs system.Extension was presumably damaged when the patient fell out of bed.Following the fall, the patient reported worsening parkinson's symptoms, particularly reduced tremor control on the right side.Xrays revealed misalignment of the lead in the extension header.During revision, reinsertion attempts of the left lead did not resolve the impedances.Troubleshooting identified the extension as the source of the impedance issue.The physician replaced the left extension, and upon connecting the new extension, all impedances were within normal limits.The explanted lead extension was retained by the hospital and will not be returned to boston scientific.The patient is doing well postoperatively with stimulation turned on at their prior settings.
Additional Manufacturer Narrative
The devices were retained by the hospital and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review did not reveal any anomalies and states that high impedances and loss of electrical connectivity are potential risks associated with the use of the deep brain stimulation (dbs) device, including failure or malfunction of any part of the device, including but not limited to lose connections, electrical shorts or open circuits.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Block b3: approximation - the patient fell out of bed and hit their head on the nightstand about 3 to 4 weeks prior to the aware date.Block d2b: additional applicable product code: nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-2202-45 serial number: (b)(6) batch/lot number: 7119298 model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7119409 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure due to high impedances.The patient had fallen out of bed and struck their head on the nightstand, related to rapid eye movement (rem) sleep behavior disorder secondary to parkinson's disease.The fall was determined not to be related to the dbs system.Extension was presumably damaged when the patient fell out of bed.Following the fall, the patient reported worsening parkinson's symptoms, particularly reduced tremor control on the right side.Xrays revealed misalignment of the lead in the extension header.During revision, reinsertion attempts of the left lead did not resolve the impedances.Troubleshooting identified the extension as the source of the impedance issue.The physician replaced the left extension, and upon connecting the new extension, all impedances were within normal limits.The explanted lead extension was retained by the hospital and will not be returned to boston scientific.The patient is doing well postoperatively with stimulation turned on at their prior settings.

• 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: 25075074
• Report Number: 3006630150-2026-02877
• Device Sequence Number: 10747921
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)260717(10)7129912
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2026
• 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
• Report Date (Section B): 05/28/2026

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: 07/17/2026
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7129912
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 07/17/2024
• 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: 60 YR
• Patient Sex: Male