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

Model Number	DB-9218-15
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device analysis was performed on the returned m8 lead adapter and confirmed the event of the patient experiencing high impedances.X-ray inspection revealed that the second lead contact was fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead extension body and connector section of the lead extension.Bending the distal end could also cause cable fractures in the connector section of the lead extension.The broken cables are still contained inside the connector.It was noted that the returned m8 adapter was never implanted due to high impedances during the deep brain stimulation (dbs) implant procedure and a different m8 adapter was implanted instead.There were no patient complications during procedure.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 18978912
• Report Number: 3006630150-2024-01786
• Device Sequence Number: 6035499
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7078481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White