Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K

FDA device recall Z-1890-2024 · posted 2024-05-24 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

Reason for recall

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

Action taken

On 4/18/24, correction notices were mailed to Physicians/Surgeons, Hospitals, Healthcare Professionals who were asked to do the following: 1) Review any patient reports of undesired sensations indicative of potential device reset behavior during IPG charging and report these observations accordingly to the firm. 2) After firm verifies this device reset behavior has occurred during IPG charging, an in-field IPG firmware update can be scheduled for the patient s device. This will eliminate the possibility of a coincident routine device system check during IPG charging, thus preventing a potential system reset. Any adverse events or quality concerns associated with use of this product should be reported to firm via email BSN.ComplaintCallCenter@bsci.com

Root cause

Device Design

Status

Open, Classified

Product code

NHL

Quantity affected

14,977

Distribution

Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO

Date initiated

2024-04-18

Date posted

2024-05-24

Location

Valencia, CA