An Iowa woman is suing after she says a medical device gave doctors the wrong information, leading to an unnecessary heart surgery that she was awake for due to “insufficient” sedation.
In August, Andrea Irwin, a 33-year-old mother, had an allergic reaction after taking a migraine medication, according to a civil complaint. The allergic reaction led to Irwin needing a cardiac monitor.
Irwin was fitted for a ZOLL brand monitor. Then, after September, she was given a replacement monitor because the first one had a faulty clip, according to the lawsuit.
The monitor sent data to ZOLL, which then tracked the data and produced results in a report.
McClatchy News reached out on July 17 to ZOLL Laboratory Services LLC, listed as the defendant in the case, but did not immediately hear back.
After Irwin received her replacement monitor, she started getting results indicating “several potentially serious cardiac events,” according to the lawsuit, which was filed July 3.
“The cardiac monitor outputs recorded by Andrea’s second ZOLL cardiac monitor, including the long sinus pauses of greater than three seconds, are potentially serious or life-threatening for a patient like Andrea Irwin,” the lawsuit said.
After receiving this data from ZOLL, doctors ordered a pacemaker for Irwin, according to the complaint.
“Their decision to surgically implant a pacemaker was reasonable and necessary based on the data reported by the ZOLL Labs’ cardiac monitor,” the lawsuit said.
When Irwin went in for surgery, she was given “insufficient sedation,” causing her to be awake for the procedure, according to the lawsuit.
“Irwin was awake, aware, and felt the procedure as it happened — an agonizing and traumatic situation. … Andrea has full memory of nearly the entire initial pacemaker surgery.
“Andrea has specific memory of the surgeon slicing into her body to open up the chest cavity; of the surgeon placing wires directly into one of the chambers of her heart; of the doctors stretching and pulling to create a cavity for the pacemaker itself to be placed inside of her body; of injections intended (but failing) to numb the area; and of the doctors finally, mercifully stitching her back up to complete the procedure,” the lawsuit said.
The court documents said during the surgery Irwin experienced “extreme pain, fear, a terror reaction, and severe emotional distress.” She also said she had post-traumatic stress disorder following the procedure.
Then, weeks after the surgery, it was discovered that the data being received from ZOLL was not coming from Irwin’s cardiac monitor, but from “a different, unknown patient,” according to the lawsuit.
“ZOLL had switched the data from two separate patients, a blatant mistake with serious consequences for patient care and safety,” the lawsuit said.
This meant that the pacemaker and surgery were “completely unnecessary,” according to the lawsuit. Irwin had to then go through a second surgery to remove the pacemaker, the complaint said.
ZOLL covered the costs of the pacemaker removal, according to the suit.
The lawsuit is asking for unspecified damages.
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