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

Model Number	DB-9218-55
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: 543416.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation resulting in a lack of tremor control.High impedance readings were observed, and the physician assessed that a fall that had occurred several months prior was a contributing factor.Reprogramming attempts were unsuccessful, and the patient underwent a procedure for surgical troubleshooting.During the procedure, when disconnecting and reconnecting the m8 adapter from the implantable pulse generator (ipg) did not resolve the impedance issues, the m8 adapter was replaced.When the impedance readings were abnormal for what would be expected when connecting to a non-boston scientific lead, the ipg was replaced.The patient did well postoperatively, and impedance readings were within normal limits.
Additional Manufacturer Narrative
X-ray inspection of the returned lead revealed that electrodes 2 and 3 of the distal ends had a fractured cable at the weld nugget; the broken cables were contained inside the connector.This type of damage typically occurs when excessive tensile force is exerted onto the m8 adapter body and connector section of the m8 adapter.Bending the distal end can also cause cable fractures in the connector section of the m8 adapter.Analysis of the returned ipg revealed it would not charge despite multiple charging attempts, and communication could not be established with a known working remote control (rc) or clinician programmer (cp).Therefore, the data logs could not be retrieved, and no functional testing could be performed.The ipg was then cut open, and internal electrical measurements revealed an excessive sleep current of 4.726 miliamps (ma), and a low impedance of 773.8 ohms on the high voltage node.This confirmed that the application-specific integrated circuit (asic) chip was damaged.This damage is typically caused by the ipg or lead being exposed to high voltage/high current transients.A review of the product labeling/instructions for use (ifu) was conducted, and revealed falls, loss of adequate stimulation, and open circuits are known inherent risks of use with the device.Additionally, the ifu indicates that use of diagnostic ultrasonic scanning, electrocautery, external defibrillation, lithotripsy, radiation therapy, and x-ray and computed tomography (ct) scans can result in damage to the device.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation resulting in a lack of tremor control.High impedance readings were observed, and the physician assessed that a fall that had occurred several months prior was a contributing factor.Reprogramming attempts were unsuccessful, and the patient underwent a procedure for surgical troubleshooting.During the procedure, when disconnecting and reconnecting the m8 adapter from the implantable pulse generator (ipg) did not resolve the impedance issues, the m8 adapter was replaced.When the impedance readings were abnormal for what would be expected when connecting to a non-boston scientific lead, the ipg was replaced.The patient did well postoperatively, and impedance readings were within normal limits.

• 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: 18728072
• Report Number: 3006630150-2024-00771
• Device Sequence Number: 6349928
• Product Code: MHY
• UDI-Device Identifier: 08714729905295
• UDI-Public: 08714729905295
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/08/2024

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: 02/13/2024
• Device Model Number: DB-9218-55
• Device Catalogue Number: DB-9218-55
• Device Lot Number: 7070067
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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: 79 YR
• Patient Sex: Female