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	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient, who was implanted with a non-boston scientific lead and boston scientific deep brain stimulator lead adaptor had abnormal impedance measurements.It was assessed that the abnormality was in the non-boston scientific lead extension, and therefore the patient underwent a revision procedure in which the lead extension was replaced.The impedances were checked during the operation, and it was discovered that there were no abnormalities with the non-boston scientific leads or extensions.The physician replaced the boston scientific adaptor, and after doing so, the impedance returned to normal.No additional adverse patient effects were reported.The physician assessed the event could possibly be due to the medical adhesive applied on the insertion port of the m8 lead adapter during the implant procedure; the adhesive may have either peeled away or had been applied too thinly thus leading to fluid entering.
Event or Problem Description
It was reported that the patient, who was implanted with a non-boston scientific lead and boston scientific deep brain stimulator lead adaptor had abnormal impedance measurements.It was assessed that the abnormality was in the non-boston scientific lead extension, and therefore the patient underwent a revision procedure in which the lead extension was replaced.The impedances were checked during the operation, and it was discovered that there were no abnormalities with the non-boston scientific leads or extensions.The physician replaced the boston scientific adaptor, and after doing so, the impedance returned to normal.No additional adverse patient effects were reported.The physician assessed the event could possibly be due to the medical adhesive applied on the insertion port of the m8 lead adapter during the implant procedure; the adhesive may have either peeled away or had been applied too thinly thus leading to fluid entering.
Additional Manufacturer Narrative
X-ray inspection of the returned m8 adaptor revealed contacts 1 and 2 were fractured after the weld in the distal connector stack.This type of damage occurs when excessive tensile force is exerted onto the lead adaptor body and connector section of the lead adapter.Bending the distal end could also cause cable fractures in the connector section of the lead adaptor.The broken cables are still contained inside the connector.

• 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: 16040387
• Report Number: 3006630150-2022-07197
• Device Sequence Number: 6437625
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: Lay User/Patient
• Device Expiration Date: 03/21/2023
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7072373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2021
• 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