In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. Boston Scientific said the reset behavior occurs in response to the presence of potential interference during IPG charging. The IPG reset behavior is random and remote. Patients with devices exhibiting this reset behavior may not report any discernible impact.
Boston Scientific received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Upon investigation, it was determined that the device may reset due to detecting noise or interference during IPG charging. This temporarily interrupts programmed stimulation lasting approximately 10-15 seconds before resuming normal operation.
According to the warning letter, there have been 32 reports of reset behavior during charging with only one case needing intervention or device replacement. Boston Scientific also said that some instances of this behavior have been reported with no discernable impact on patients.
While performance data indicates that Vercise Genus DBS IPGs meet established product expectations for safety and performance, Boston Scientific has identified areas for improvement. This includes implementing an IPG firmware update for implanted devices to prevent device resets during charging. This update eliminates the possibility of routine system checks coinciding with IPG charging, thereby averting potential system resets.
Boston Scientific field representatives are equipped to install the firmware update on implanted IPGs for patients who have experienced undesired sensations during IPG charging due to device reset behavior.
