July 28, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. – Boston Scientific called a single pacemaker-related death for its S-ICD implant a “fluke” that was the result of radiation corruption that negatively impacted the device’s memory.
In a letter sent to physicians last month, Boston Scientific said the patient’s S-ICD pacemaker “repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation within the environment,” Mass Device reported this morning. In the letter, the company said the corruption prevented arrhythmia detection/treatment, which resulted in the patient’s death. The company went on to note that the radiation was from an ionized subatomic particle. However, Mass Device noted that there was no evidence at the time of the reporting that the patient had received ionized radiation therapy prior to his death.
According to the report, Boston Scientific engineers conducted a three-week investigation that included experiments attempting to replicate the freak radiation occurrence. After three weeks, Mass Device said Boston Scientific officials concluded the event was a one-time occurrence, which they dubbed as a “single event upset.” In its letter, the company said the event involved “a change of state in the device memory induced by environmental radiation interacting with a specific memory location.” Boston Scientific said the probability of a similar event occurring was one in 300,000, according to the report.
The company though is taking steps to further reduce the chances of a similar event happening by developing a new software program to mitigate memory corruption from any sort of odd energy delivery.
“We expect software to be completed in July with submissions to Regulatory Authorities shortly thereafter,” the company said in the letter, according to the report. “Based on information received during the investigation, it does not appear that the patient was subjected to any readily identifiable external source of ionized particles (e.g., ionizing radiation therapy) prior to the event.”
Additionally, Boston Scientific said the “fluke” event with the pacemaker “cannot occur with any Boston Scientific transvenous defibrillators or pacemakers due to differences in hardware and software.”
The company added that it recommended no changes to clinical follow-up with patients due to the single event.
While Boston Scientific looks to update the pacemaker software to mitigate any additional radiation corruptions, the company is also planning to seek regulatory approval for its Lotus heart valve. The company announced its intentions during an earnings call earlier this week, according to the Minneapolis Star Tribune. Boston Scientific plans to submit data to the U.S. Food and Drug Administration by the end of the year. In its earnings report, Boston Scientific beat Wall Street expectations, posting a 6 percent growth in net sales.
Last year, the company saw several FDA approvals, including two catheters that can be used with the Rhythmia Mapping System and approval for a suite of products deemed safe for use in MRI environments, including two new pacemakers and a pacing leads system.Shares of Boston Scientific are down this morning, trading at $26.95.
