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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a scheduled deep brain stimulation (dbs) elective procedure a high impedance was discovered during functional testing on contacts e1 and e2.Attempts to clear the high impedances was performed, however were unsuccessful.The physician replaced the lead extension with another of the same model as a result additional functional testing revealed the high impedances had resolved and proceeded to complete the procedure.No adverse effects were noted from the high impedance issue.The patient did well post-operatively.
Additional Manufacturer Narrative
Block a2: patients exact age is unknown; however, it was reported that the patient was over the age of 18.
Additional Manufacturer Narrative
The returned vercise lead extension was analyzed and the reported event of high impedance was confirmed.Visual inspection revealed the proximal array was fractured approximately one centimeter from the retention sleeve.The damage to the lead extension was likely a result of stress caused by the skiving tool in manufacturing during removal of the heat shrink causing the cables to kink in the proximal tail, additionally slack in the cables during proximal reflow could also contribute to kinks.Therefore, engineers concluded that the probable cause was manufacturing deficiency.
Event or Problem Description
It was reported that during a scheduled deep brain stimulation (dbs) elective procedure a high impedance was discovered during functional testing on contacts e1 and e2.Attempts to clear the high impedances was performed, however were unsuccessful.The physician replaced the lead extension with another of the same model as a result additional functional testing revealed the high impedances had resolved and proceeded to complete the procedure.No adverse effects were noted from the high impedance issue.The patient did well post-operatively.

• 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: 21734348
• Report Number: 3006630150-2025-02020
• Device Sequence Number: 4222960
• Product Code: NHL
• UDI-Device Identifier: 08714729966371
• UDI-Public: 08714729966371
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/02/2022
• Device Model Number: DB-3128-55
• Device Catalogue Number: DB-3128-55
• Device Lot Number: 5000609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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
• Patient Sex: Unknown