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	Undesired Nerve Stimulation (1980)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(4), batch: 7070860.
Event or Problem Description
It was reported that the patient experienced high impedances on the lead contacts 1 and 9 and undesired sensations in a non-target stimulation area on her back.The patient has both boston scientific lead adapters and a competitors leads implanted.The patient underwent a revision procedure and the two adapters were explanted and replaced.After the adapters were replaced, the high impedance issue was resolved.The physician noted that the first contact on both adapters were broken.The patient is doing well postoperatively and has fully recovered.
Additional Manufacturer Narrative
With the available information, boston scientific concludes that the event of high impedances and undesired sensations were caused by lead extension fractures identified during laboratory analysis, which is also a known risk with the use of deep brain stimulation.Device technical analysis: the returned lead extension adapters db-9218-15 serial number (b)(6) were analyzed and x-ray inspection revealed fractured cables # 1 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.Labeling review: a product labeling review identified that the devices were used per the instructions for use (ifu) product label.Additionally, the ifu states that malfunction of any of the device components or the battery, including but not limited to lead or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, whether or not this requires explant and/or reimplantation is a known risk with the use of deep brain stimulation.
Event or Problem Description
It was reported that the patient experienced high impedances on the lead contacts 1 and 9 and undesired sensations in a non-target stimulation area on her back.The patient has both boston scientific lead adapters and a competitor's leads implanted.The patient underwent a revision procedure and the two adapters were explanted and replaced.After the adapters were replaced, the high impedance issue was resolved.The physician noted that the first contact on both adapters were broken.The patient is doing well postoperatively and has fully recovered.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12229987
• Report Number: 3006630150-2021-04058
• Device Sequence Number: 11979139
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 11/16/2021

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: 06/24/2022
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7071007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown