Man was not told of alert regarding pacemaker

AN inquest into the death of a man whose defective pacemaker failed on a flight to France heard a warning had been issued by the manufacturer four months earlier, but the hospital failed to inform him.

James Kinsella, aged 74, of Grove Heights, Seamount, Cortown, Co Wexford, suffered a cardiac arrest when his pacemaker stopped working on a flight from Dublin to Beauvais on September 17, 2009.

The flight was diverted back to Dublin and Mr Kinsella, who was travelling to Paris with his wife Mary Patricia to visit their son, was rushed to Beaumont Hospital, Dublin.

Doctors found his pacemaker was not working and inserted a replacement device. The father of three sons was left brain damaged due to the prolonged cardiac arrest and died a week later.

A subsequent test by the device manufacturers, Medronic, found the device was defective.

Mr Kinsella’s pacemaker was one of a range called Sigma, which was the subject of an alert by the manufacturers in May 2009, Dublin City Coroner’s Court heard.

The risk identified was one of sudden, no output of the device, and physicians were advised that they might consider an elective change in the device for patients who had become pacemaker-dependent.

The incidence of faulty devices is very small, somewhere between 0.4% and 0.8%, the inquest was told.

Mr Kinsella, who was pacemaker-dependent, had a pacemaker check at Wexford General Hospital on July 7, 2009, two months after the warning.

Speaking from the body of the court, Mr Kinsella’s son, Brian, said the family had been told by the (Wexford) hospital that his father hadn’t been informed (about the warning) and that there had been a “breakdown in communications.”

A report from Wexford General Hospital indicated there was a “disconnection” between the warning by Medtronic and it being linked to Mr Kinsella’s pacemaker box, which the report described as “a human error.”

“It would appear the connection between the warning and Mr Kinsella’s pacemaker box wasn’t made,” said coroner Dr Brian Farrell.

“There was a communications failure,” he said.

Dr Farrell recorded a verdict of medical misadventure taking into account two risk factors: the failure of the pacemaker device and the communications issue.

He said he would write to Wexford General and ask it to review its procedures in light of what had happened.

Consultant cardiologist at Beaumont Hospital Dr Thomas Gumbrielle said if Mr Kinsella’s pacemaker had been changed, it was likely Mr Kinsella would be alive.

“He would have lived to die from something else, which was likely to be cardiac,” said Dr Gumbrielle, who said he had never seen a pacemaker fail like this.

Mr Kinsella had severe coronary heart disease and enlargement of the heart.

After the May warning the consultant cardiologist reviewed and called in his patients (with the devices) for a check-up, the inquest heard.

Because of what happened to Mr Kinsella, he brought everybody in and changed the pacemakers.

Brian Kinsella said that after a check at Wexford General in January 2009, his father said that his pacemaker was to be changed, but after the meeting in July, his father said everything was okay.

Mr Kinsella was given an appointment for three months’ time.

The coroner expressed his condolences to Mrs Kinsella and her two sons, Brian and Seamus.

“It must have been very traumatic for you, Mrs Kinsella,” he said.

Her other son, Phelim, is based in Paris and did not attend the inquest.