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

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

In her lawsuit, she alleges 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, 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 that she was awake and aware throughout the operation. The lawsuit describes the procedure as “an agonizing 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 realized the heart-rate data attributed to Irwin’s monitor was erroneous and was actually tied to a different patient. The error was discovered only after ZOLL posted data onto 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. “Andrea Irwin’s 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, traumatizing 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 medical 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.

An Iowa physician is taking the state’s Board of Medicine to court in an effort to gain access to its investigative files on him.

Dr. Hamza Alsayouf of Des Moines is suing the Iowa Board of Medicine in Polk County District Court, alleging it is in violation of state law by refusing to turn over all of its information on him.

Alsayouf alleges that on Feb. 29, 2024, the board staff sent him an “inquiry about certain criminal allegations which allegedly occurred in a foreign country.” Alsayouf says he has advised the board that he does not know anything about the alleged criminal matters, and that he has asked the board to turn over its investigative file on him “so he may knowledgeably respond” to the inquiry.

According to the lawsuit, the executive director of the Board of Medicine has denied the request for the investigative file, which has prompted Alsayouf to seek judicial review of that decision.

In court filings, Alsayouf acknowledges that should the board decide to file charges against him, the investigative file would be made available to him in its entirety.

The lawsuit alleges the board’s refusal to grant access to the information prevents Alsayouf from “meaningfully participating” in the investigative process. Alsayouf is asking the court to order the board to “turn over the entire investigative file on this matter” and block the board from “pursuing any additional action or filing any statement of charges” in the case until the issue of access is decided.

Iowa’s licensing boards shut off access to information on charges

In a brief filed with the court, Alsayouf’s attorney, Mike Sellers, stated the board has asked Alsayouf to narrow his request to only the information that is necessary for him to respond to the board’s inquiries. However, Sellers argues, “Alsayouf cannot ask for something he does not know exists. The best Dr. Alsayouf can do is to request, ‘Show me what you’ve got.’”

Sellers also takes issue with the board’s position that it can release some information from the investigative file but isn’t obligated to disclose everything in that file unless charges are filed.

“By restricting what information the licensee has,“ Sellers has told the court, “the board allots just enough rope to hang oneself while claiming that because they asked for a licensee’s input that he meaningfully participated in the investigative process.”

In its response to the petition for judicial review, the board argues that “releasing the investigative file prior to discipline could have a chilling effect on the process and the board’s ability to conduct meaningful investigations into complaints against licensees.”

A court hearing on the matter is scheduled for Sept. 19.

College football delivers surprises every year. Those surprises can be good or bad.

It can come in the form of an upset that no one saw coming, or in the form of a team that either positively surprises or outright disappoints.

As the 2024 season approaches, the general consensus surrounding the Iowa Hawkeyes seems to be fringe top-25 team. Most aren’t expecting Iowa to challenge Ohio State or Oregon for the Big Ten championship, but analysts expect the Hawkeyes to be one of the Big Ten’s better teams.

One national pundit that appears higher on Iowa than some others is Phil Steele. In his annual college football preview magazine, Phil Steele tabbed Iowa as one of his top surprise teams. Iowa came in at No. 7 on Phil Steele’s surprise teams list.

Here’s what Phil Steele had to say about why Iowa was his No. 7 surprise team:

Kirk Ferentz always gets the most out of his teams. Last year with no passing threat after QB McNamara went down, he once again did it with special teams and a dominating defense. This year while the offense will not be overwhelming, QB McNamara is back and they have a capable backup in Brendan Sullivan who led Northwestern to an improbable season and bowl win over Utah.

The offensive line is the best in years. The special teams remains solid. Phil Parker almost always has a top 10 defense, but this year his top four players turned down the NFL and he has eight starters back with my No. 1 LBs and No. 5 Des in the country.

They do face Ohio State on the road but could be favored in their other 11 games. They say defense wins championships and that will make them dangerous if they make the playoffs, especially with a now capable offense. – Phil Steele.

Iowa does bring back plenty of talent defensively. Linebackers Jay Higgins and Nick Jackson combine to form what is Phil Steele’s top linebackers unit in America.

Behind those two, Iowa features a secondary that includes Sebastian Castro, Quinn Schulte, Xavier Nwankpa, Jermari Harris and Deshaun Lee. The Hawkeyes have Deontae Craig and Yahya Black returning along their defensive line, too.

Offensively, new offensive coordinator Tim Lester can provide a breath of fresh air for the Hawkeyes. Plus, it’s important to remember what Phil Steele touched on.

Iowa was without starting quarterback Cade McNamara for the bulk of last season and McNamara probably wasn’t fully healthy when he did appear in five games either.

McNamara will have star tight end Luke Lachey, junior wide receivers Kaleb Brown and Seth Anderson and running backs Leshon Williams, Kaleb Johnson and Jaziun Patterson back in the fold as key offensive skill weapons.

If the Iowa offensive line turns a corner, then Phil Steele could be right on the money with a Big Ten and national sleeper. Phil Steele also included Iowa as his No. 7 surprise team entering the 2023 season.

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