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

Model Number	DB-3128-55
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a number of falls and sustained a head injury after being implanted.It was noted that the head injury was likely the cause of the high impedances per the physician's assessment, however no stimulation issues were noted.The patient underwent a procedure wherein an operating room (or) cable was just to determine the high impedance measurement was on the lead and/or lead extension.The lead extensions were replaced with others of the same model which showed the impedance within range and the leads remained implanted.The patient did well post-operatively.Additional information has not been provided despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event is unknown, approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365db3128550, model: db-3128-55, serial: (b)(6), batch: asku.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a number of falls and sustained a head injury after being implanted.It was noted that the head injury was likely the cause of the high impedances per the physicians assessment, however no stimulation issues were noted.The patient underwent a procedure wherein an operating room (or) cable was just to determine the high impedance measurement was on the lead and/or lead extension.The lead extensions were replaced with others of the same model which showed the impedance within range and the leads remained implanted.The patient did well post-operatively.Additional information has not been provided despite good faith efforts.
Additional Manufacturer Narrative
The returned dbs lead extension was analyzed, visual inspection revealed that was cleanly cut into two pieces away from proximal end.X-ray inspection revealed four of the cables were fractured after the weld in the distal connector stack however remained contained inside connector, this type of damage occurs when excessive tensile force is exerted onto the lead extension body and connector sections.A labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states failure or malfunction of any of the device components or the battery, including but not limited to the lead extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires surgical intervention, including motor problems and falls or injuries resulting from these problems are known risks with the use of dbs.With all the available information, boston scientific concludes that the probable cause is traced to component failure.Block d4: serial number updated.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 21123674
• Report Number: 3006630150-2024-09449
• Device Sequence Number: 18010868
• Product Code: NHL
• UDI-Device Identifier: 08714729966371
• UDI-Public: (01)08714729966371(17)251118(10)5002645(21)5002645
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 11/18/2025
• Device Model Number: DB-3128-55
• Device Catalogue Number: DB-3128-55
• Device Lot Number: 5002645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2023
• 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 Sex: Unknown