A US woman is suing a medical device manufacturer, alleging her heart monitor provided her doctors with data from a different patient, leading to an unnecessary, extremely painful and traumatic surgery.
In her lawsuit, Andrea Irwin, a 33-year-old mother of two who is suing ZOLL Laboratory Services and ZOLL Medical Corporation, said that in August 2023, her doctors fitted her with a ZOLL-branded heart monitor that would produce a written record of her heart rate.
The monitor allegedly recorded several potentially serious cardiac events of a life-threatening nature. As a result, reports the Des Moines Register, Irwin’s doctors ordered a pacemaker to be surgically implanted in September 2023.
According to the lawsuit, Irwin’s pacemaker was installed under insufficient sedation, which meant she was awake and aware throughout the operation.
The lawsuit describes the procedure as “an agonising and traumatic situation in which even an attending doctor noted her awareness to the procedure in real time during the surgery”.
Within days of the operation, Irwin’s doctors allegedly realised the heart-rate data attributed to Irwin’s monitor were erroneous and actually tied to a different patient.
The error was discovered only after ZOLL posted data on Irwin’s electronic medical chart showing she had a cardiac event after her operation – when she wasn’t even wearing the heart monitor.
The data that had been attributed to Irwin’s heart monitor “were completely erroneous”, the lawsuit claims.
“Her heart monitor readings were not from Andrea at all, but from another person entirely, meaning that the heart data that led her to a shocking, painful, traumatising surgery were just plain wrong.”
The lawsuit claims Irwin’s doctors then determined Irwin did not require a pacemaker at all, noting that her physician, Dr Robert Brewer, wrote in her file that “her pacemaker implantation was unnecessary” and that surgical removal of the device was recommended.
ZOLL Labs allegedly paid the medical costs and expenses for removal of Irwin’s pacemaker, the lawsuit alleges.
Irwin’s lawsuit seeks unspecified damages for negligence and for loss of consortium involving Irwin’s relationship with her husband and co-plaintiff, John Irwin.
ZOLL has yet to file a response to the lawsuit.
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