In 1992, an episode of the iconic TV show Law & Order aired a storyline that now feels eerily prescient. The episode revolved around a teenage boy who dies due to a faulty pacemaker. As detectives dig deeper, they discover multiple pacemaker-related deaths linked to the same manufacturer.
Fast forward 34 years, and the real world seems to echo this fictional tale. Boston Scientific, a leading pacemaker manufacturer, has faced scrutiny for battery malfunctions in its devices.
The parallels between the Law & Order episode and Boston Scientific’s real-life controversy highlight how fiction can sometimes foreshadow reality. While the TV show’s storyline was purely fictional, it raises thought-provoking questions about corporate accountability and the safety of life-critical medical devices.
Why the Law & Order connection matters
The Law & Order episode serves as a reminder of the importance of vigilance in the medical device industry. It underscores the need for transparency, rigorous testing, and timely action to prevent tragedies like those depicted in the show — or experienced by real patients like Gladys Knepper, whose story brought Boston Scientific’s pacemaker issues to light in a recent investigative report in The New York Times.
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According to The Times report, Knepper died at age 93 after her Boston Scientific pacemaker battery failed. Before the battery failure, Knepper had been, according to her daughter, June Knepper, independent enough to do her own laundry, cook herself meals, and take her medications independently. Although she had underwent surgery to replace the faulty device, by then, her heart was severely damaged, and she died three weeks later, The Times reported.
Pacemaker battery problems are nothing new
Of course, pacemaker battery issues are nothing new to Boston Scientific or other pacemaker manufacturers.
While The Times article focuses on the Accolade pacemakers, which are the subject of a recall that now includes 1.6 million devices, Boston Scientific had previously had battery problems involving its Ingenio pacemakers.
Back in 2015, competitor Medtronic recalled roughly 96,800 InSync III pacemakers due to a potential battery defect.
Battery problems are also not limited to pacemakers but have, in the past, involved other implantable heart devices as well. In 2016, before Abbott acquired St. Jude Medical, battery problems in St. Jude implantable cardioverter defibrillators were linked to two patient deaths and a major recall.
Making batteries for implantable devices is hard to do
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There’s no denying that manufacturing batteries for implantable devices is a challenge.
“Batteries must perform reliably and predictably over periods of 10 or more years,” Brian Hohl, product development engineering manager at Integer, told Battery Technology, MD+DI’s sister publication. “Assessing manufacturing changes to materials or processes to ensure there are no long-term impacts to battery performance is probably the most challenging aspect of battery manufacturing. Exacting quality controls and an in-depth understanding of the materials and processes are required.”
Hohl said that before any specific battery is designed, Integer fully characterizes the chemistry and develops a set of detailed design rules. Long-term performance modeling, accelerated life-testing, and specific quality requirements are all used to ensure the impact of any change is well understood, he said.
Hohl also acknowledged that power sources for implanted medical devices are under increasing scrutiny by regulators.
“Device manufacturers are being challenged to provide more evidence to justify their longevity claims. Short-term or accelerated data is no longer sufficient for making long term claims,” Hohl said. “Battery makers must be able to provide validated performance modeling that covers device use conditions.”
