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

Model Number DB-9218-55

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Shaking/Tremors (2515)

Event Date 02/02/2024

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 335709370
• Report Number: 3006630150-2024-00771
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female