MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	NM-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced erosion of the skin at the lead extension and leads site of the deep brain stimulation (dbs) system due to the consistent continuous positive airway pressure (cpap) usage and the strap going directly over the lead extension connection site.The patient underwent an explant procedure in which the lead extensions and the ipg were explanted to allow for healing and re-implant at a later time.The physician stated that the patient did not experience any additional symptoms due to the erosion, no additional findings were identified during the procedure, and the patient was tested for infection and the results were negative.The patient is stable post-operatively, and the devices will not be returned for analysis as they were disposed of by the facility.
Event or Problem Description
It was reported that the patient experienced erosion of the skin at the lead extension and leads site of the deep brain stimulation (dbs) system due to the consistent use of the continuous positive airway pressure (cpap) and the strap going directly over the lead and lead extension connection site.The patient underwent an explant procedure in which the leads, were explanted to allow for healing and re-implant at a later time.The physician decided to also explant the lead extensions and ipg to remove any possibility of future infection.The physician stated that the patient did not experience any additional symptoms due to the erosion, no additional findings were identified during the procedure, and the patient was tested for infection and the results were negative.The patient is stable post-operatively, and the devices will not be returned for analysis as they were disposed of by the facility.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: 7134370.Model/catalog description: 55 cm 8 contact extension.Unique identifier (udi) # (b)(4).Model number/catalog number: db-1216.Serial number: (b)(6).Batch/lot number: 775028.Model/catalog description: vercise genus r16 ipg kit.Unique identifier (udi) # (b)(4).Model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7124842 and 7124870.Model/catalog description: dbs directional lead sterile kit 45 cm.Unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: nm-3138-55.Serial number: (b)(6).Batch/lot number: 7134370.Model/catalog description: 55cm 8 contact extension.Unique identifier (udi) # (b)(4).Model number/catalog number: db-1216.Serial number: (b)(6).Batch/lot number: 775028.Model/catalog description: vercise genus r16 ipg kit.Unique identifier (udi) # (b)(4).Model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7124842 and 7124870.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing erosion at the lead extension site and undergoing an explant procedure in which the ipg, leads, and lead extensions were explanted could not be confirmed based on record review as the devices were discarded and not returned for analysis.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The devices were discarded by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states implanted device components may move from original implanted location or wear through the skin, which may lead to the need for additional surgery.Based on all available information, engineers are not able to confirm the root cause of the event.The devices were not returned, as such, physical analysis could not be conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint, and the conclusion is cause not established.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50245639
• Report Number: 3006630150-2026-05888
• Device Sequence Number: 10070281
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)261117(10)7134246
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7134246
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/17/2024
• 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: 74 YR
• Patient Sex: Male