FDA Exemption Allows World's Smallest Pacemaker for Pendleton Baby
11/08/00 Portland, Ore.
Experimental, Quarter-sized Device Used for Baby Born Six Weeks Early.
The Food and Drug Administration has granted a humanitarian exemption for use of a new pacemaker for a premature baby born at Oregon Health Sciences University Hospital in late September. The baby, Alexandra Schuck, was born six weeks early due to a congenital heart condition that threatened her life in the womb. She was fitted with the quarter-sized pacemaker just after birth and today received her six-week checkup.
The new pacemaker, called a Microny and developed by St. Jude Medical, is about a third the size of a traditional pacemaker and is undergoing clinical trials for FDA approval. "The device has been proven to work so far in trials and this baby could have had dire complications without it, so we appealed to the FDA to let us use it in this instance and they complied," said Seshadri Balaji, M.D., pediatric cardiologist at OHSU.
Alexandra's parents, Charles and Erin Schuck of Pendleton, said their doctor noticed a problem with the baby about four months into the pregnancy. "They said the electrical charges in her heart weren't formed, so I was referred to Doernbecher Children's Hospital," Erin said. The baby was monitored throughout the pregnancy and doctors became concerned when they noticed an accumulation of fluid around the heart. That's when doctors induced the birth at 35 weeks.
"Because of Alexandra's heart problems, she will always need a pacemaker, but that should not have any adverse affect on her life," said Balaji. The tiny pacemaker performs all the functions of a regular pacemaker, so it is possible doctors will not need to replace it with a regular-sized one even when this pacemaker runs its course.
At her six-week checkup, Alexandra's pacemaker was checked for proper functioning and battery power. Doctors also gave her parents a special phone monitor to take home. That device allows them to call each month and perform a routine pacemaker checkup over the phone.