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Iowa woman claims her heart monitor provided data from another patient • Iowa Capital Dispatch
Iowa woman claims her heart monitor provided data from another patient • Iowa Capital Dispatch

An Ankeny woman is suing a medical device manufacturer, alleging that her heart monitor provided her doctors with data from another patient, leading to an unnecessary surgery.

Andrea Irwin, a 33-year-old mother of two from Ankeny, is suing ZOLL Laboratory Services and ZOLL Medical Corp. in the U.S. District Court for the Southern District of Iowa.

In her lawsuit, she claims that in August 2023, her doctors fitted her with a ZOLL brand heart monitor that would record her heart rate in writing.

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The monitor reportedly recorded several potentially serious cardiac events of a life-threatening nature. As a result, Irwin’s doctors ordered the surgical implantation of a pacemaker in September 2023.

According to the lawsuit, Irwin’s pacemaker was inserted under inadequate sedation, meaning she was awake and conscious throughout the entire surgery. The lawsuit describes the procedure as “an agonizing and traumatic situation in which even an attending physician noticed in real time during the surgery that she was aware of the procedure.”

Irwin’s doctors reportedly noticed within days of the surgery that the heart rate data recorded by Irwin’s monitor was inaccurate and actually related to another patient. The error was not discovered until ZOLL entered data into Irwin’s electronic medical record showing that she had suffered a cardiac event after the surgery, even though she was not wearing the heart monitor.

The data attributed to Irwin’s heart monitor “was completely false,” the lawsuit says. “Andrea Irwin’s heart monitor readings did not come from Andrea at all, but from an entirely different person. This means that the heart data that led to her undergoing a shocking, painful and traumatizing surgery was simply false.”

The lawsuit alleges that Irwin’s doctors then determined that Irwin did not need a pacemaker at all. Her doctor, Dr. Robert Brewer, wrote in her medical records that “implantation of her pacemaker was unnecessary” and that surgical removal of the device was recommended.

ZOLL Labs allegedly covered the medical costs and expenses of removing Irwin’s pacemaker, the lawsuit says.

Irwin’s lawsuit seeks unspecified damages for negligence and for loss of spousal support related to her relationship with her husband and co-plaintiff, John Irwin.

ZOLL has not yet responded to the lawsuit.

By Liam