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

Model Number	DB-3128-95B
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the second stage implant procedure, the physician connected the new deep brain stimulation lead to the previously implanted lead extension and most contacts displayed high impedances.It is unknown if the issue was present at the original implant stage or caused at this second stage implant procedure.However, the physician replaced the lead extension with a new extension which resolved the impedances.The original lead extension was cut at both the proximal and distal ends and a portion remains in the patients neck.There were no reported complications and the patient was doing well postoperatively.The explanted lead extension portions were discarded by the medical facility.
Event or Problem Description
It was reported that during the second stage implant procedure, the physician connected the new deep brain stimulation lead to the previously implanted lead extension and most contacts displayed high impedances.It is unknown if the issue was present at the original implant stage or caused at this second stage implant procedure.However, the physician replaced the lead extension with a new extension which resolved the impedances.The original lead extension was cut at both the proximal and distal ends and a portion remains in the patients neck.There were no reported complications and the patient was doing well postoperatively.The explanted lead extension portions were discarded by the medical facility.

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 18230992
• Report Number: 2124215-2023-67542
• Device Sequence Number: 20174875
• Product Code: NHL
• UDI-Device Identifier: 00191506023584
• UDI-Public: 00191506023584
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/15/2023

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: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: DB-3128-95B
• Device Catalogue Number: DB-3128-95B
• Device Lot Number: 5000080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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: 50 YR
• Patient Sex: Male