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

Model Number DB-1216

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

Patient Problems Shaking/Tremors (2515); Movement Disorder (4412); Speech Disorder (4415)

Event Date 08/01/2023

Event Type  Injury  

Event Description

It was reported the patient experienced inadequate stimulation resulting in tremor, and difficulty walking and speaking.The physician assessed the presence of high impedance measurements.The patient underwent a revision procedure where the implantable pulse generator (ipg) was replaced.No further information has been provided despite good faith efforts.

Manufacturer Narrative

The returned ipg was linked to a clinician programmer (cp) and high impedance measurements were observed.X-ray inspection of the ipg revealed a fractured feedthru ground wire.Engineers concluded the cause of the high impedances and the resulting impact to the patient therapy was the result of the fractured/broken proximal feedthru wire that connects to the case of the ipg.If the proximal feedthru wire that is connected to the case is compromised, stimulation capability will be compromised (as well as mri immunity) and monopolar impedance measurements will report high.Additionally, bluetooth low energy (ble) wire was also fractured.

Event Description

It was reported the patient experienced inadequate stimulation resulting in tremor, and difficulty walking and speaking.The physician assessed the presence of high impedance measurements.The patient underwent a revision procedure where the implantable pulse generator (ipg) was replaced.No further information has been provided despite good faith efforts.

• Brand Name: VERCISE GENUS
• Type of Device: 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18188442
• MDR Text Key: 328738025
• Report Number: 3006630150-2023-07261
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 557728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 65 KG