'Insufficient sedation': Woman's faulty heart monitor prompted needless surgery that she was left awake for, lawsuit says

Background: An empty hospital bed (Nuttapol Pingpittayakun/Shutterstock). Inset: A Zoll Laboratory medical device (Andrew Irwin).

It was one horrible experience after another for a 33-year-old woman in Iowa who claims that a faulty heart rate monitor led her to undergo an unnecessary and traumatic surgery that she wasn’t even sufficiently sedated for — so she was left awake during the procedure.

Arkeny, Iowa, couple Andrea and John Irwin filed their civil complaint against heart monitor manufacturer Zoll Laboratory Services LLC and its subsidiary Zoll Medical , based in Pennsylvania and Massachusetts respectively.

According to the complaint obtained by Law&Crime on Thursday, Andrea Irwin says that in August 2023 she had an allergic reaction to migraine medication that prompted her to end up in the emergency room in Des Moines.

Doctors at the Iowa Methodist Medical Center diagnosed Irwin with tachycardia, or a heartbeat that flutters faster than 100 beats per minute.

Fitted with a Zoll-branded cardiac monitor, Irwin says the company is “more than the manufacturer of this medical device — it assumed an active role in the monitoring of Andrea’s heart rate, contacting her directly to note the serial number and provide instruction,” the lawsuit states.

Irwin included a log of data relayed to Zoll which showed the ongoing cardiac monitoring and how over a week in late August 2023, the device registered a tachycardia event occurring several times.

Irwin claims she was fitted with another entirely new heart monitoring device in short order “due to a faulty clip on the first” product though she had not asked for a new one.

The woman said her concerns were first raised when she noted mismatched serial numbers on the devices after the switch. The second monitor, she alleges, again recorded multiple life-threatening alerts.

This time, Irwin said her doctors told her she must be fitted with a pacemaker.

“Andrea’s pacemaker was installed under insufficient sedation, which means that Andrea was awake, aware and felt the procedure happen — 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.”

Andrea Irwin says she has “full memory” of the surgery and particularly the surgeon:

[S]licing into her body to open up the chest cavity, of the surgeon placing wires directly into one of the chambers of her heart, the doctors stretching and pulling the cavity for the pacemaker itself to be placed inside 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.

According to the civil complaint, she has post-traumatic stress disorder from the event and was left with physical scars marring her body as well.

What Irwin said she learned not long after the surgery was horrifying: The data that was recorded by Zoll and then used as the premise for her surgery was “completely erroneous and faulty.”

“The data was actually from a different, unknown patient, and not Andrea Irwin,” the lawsuit alleges. “Zoll had switched the data from two separate patients, a blatant mistake with serious consequences for patient care and safety.”

“The data disaster at Zoll Labs was only uncovered when Zoll posted a cardiac event onto Andrea Irwin’s electronic chart after her nightmarish pacemaker procedure — while she was no longer wearing the monitoring device, which would have made recording and reporting that event impossible,” the complaint states.

A visit with her doctors after seeing this allegedly confirmed it.

“Pacemaker: I would agree that her pacemaker implantation was unnecessary,” Irwin’s doctor wrote in a note post-surgery.

Irwin is suing for negligence and seeks a jury trial with damages to be determined — but in an amount that “far exceeds $75,000,” the lawsuit says.

Zoll Laboratory Services LLC declined to comment on Thursday.

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