DES MOINES, Iowa — An Ankeny woman is suing a medical device manufacturer, claiming faulty data from a heart monitor device led her to receive unnecessary surgery.
Andrea Irwin, a 33-year-old mother of two, claims in her lawsuit against ZOLL Medical Corp. and ZOLL Laboratory Services that her heart rate monitor device was receiving data from another patient. The lawsuit was filed in the U.S. District Court of the Southern District of Iowa.
In early August 2023, Irwin had an allergic reaction to migraine medication and experienced tachycardia, a heart rate faster than 100 beats per minute. Her doctors decided to fit her with a ZOLL-branded heart rate monitor to collect heart rate data.
After being fitted for a different monitor from the company in September 2023, it allegedly recorded several potentially serious cardiac events that could’ve been life-threatening. According to the lawsuit, due to these reported events, her doctors decided to surgically implant a pacemaker later that month.
Irwin’s pacemaker was installed under “insufficient sedation,” the lawsuit claims, meaning she was awake, aware and felt the procedure as it was happening. For Irwin, it was “an agonizing and traumatic situation in which even an attending doctor noted her awareness to the procedure in real time during the surgery, but was unable to provide additional sedation.”
The lawsuit describes Irwin’s memory of nearly the entire surgery in which she experienced extreme pain, fear, terror and severe emotional distress. Irwin developed post-traumatic stress disorder in the aftermath of the incident, the lawsuit states.
Irwin’s doctors later observed that the heart rate data supposedly belonging to Irwin was “completely erroneous and faulty,” and instead came from a different, unknown patient, “meaning that the heart data that led her to a shocking, painful, traumatizing surgery were just plain wrong.”
The lawsuit says the mistake was discovered after a cardiac event was reported on Irwin’s records after her pacemaker surgery when she was not wearing the monitoring device, making such an event impossible.
With the recommendation from her doctors, including a note in her medical file from her physician, Dr. Robert Brewer, that “her pacemaker implantation was unnecessary,” Irwin's pacemaker was surgically removed.
According to the lawsuit, ZOLL Labs paid the medical costs and expenses for removing Irwin’s pacemaker.
Irwin’s lawsuit claims ZOLL mishandled her medical data and lacked proper oversight, seeking unspecified damages for negligence and loss of consortium with her husband and co-plaintiff, John Irwin.
As of Monday, ZOLL has yet to respond to the lawsuit.