Robert at fifteen

Our son’s name was Robert Wallace Baird.  He died on September 14th, 2006 at the age of 16.  Robert died with a pacemaker implanted in his body, a device we would come to find out was subsequently recalled by the FDA for what appears to be the exact problem that was found with the device at the time of Robert’s death.

On July 29, 1994, at 4½ years of age, Robert was diagnosed with second degree heart block. On August 9th, 1996, at 7 years of age, Robert received his first pacemaker. We were told that our son would live a full life and were advised not to worry about the pacemaker.

On October 26, 2002, Robert’s pacemaker failed due to a lead fracture.  Robert received his second pacemaker on November 5, 2002.

In November, 2005 a small subset of Robert’s pacemaker was recalled due to “separation of redundant interconnect wires”.  The recall stated, “This subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or no output.”  In addition, the recall noted that “Hybrid circuits used in this subset of devices were cleaned during manufacture with a particular cleaning solvent that could potentially reduce the strength of the interconnect wire bond over time.”  Unfortunately, we were not made aware of this recall.

On September 3, 2006, while on vacation, my son took an afternoon nap. While I told myself that Robert never takes afternoon naps, I thought nothing of it. He was a teenager and he had an active day. Robert was not one to complain because he was busy living his life as all teenage boys do.

On the morning of September 14, 2006, Robert’s sister and brother, Mary and Jeremy, awoke to noises coming from Robert’s room at 5:30 in the morning. Mary walked into his room and then rushed to wake Janis and myself. The paramedics spent several hours trying to revive Robert and transported him to the hospital where he was pronounced dead.

On October 3, 2006, we received a letter from the device manufacturer regarding Robert’s pacemaker. It had this to say: “The generator was opened for further testing. Analysis found the wire(s) connecting the battery to the hybrid had lifted at the bond pads.”

On June 11, 2009, the FDA issued a Class I recall on the remaining pacemakers “due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.”

Due to the Riegel v. Medtronic decision the Supreme Court has prevented any patient of a medical device to take their case to court unless their is a manufacturing defect. A fatal design approved by the FDA will protect the manufacturer with no recourse to the patient.  Medical device patients are now fully dependent on the FDA, a politically controlled federal agency, for their safety with no recourse to their injuries or death, as in the case of Robert.

I am not here to debate the merits of Robert’s case. I am fighting to get Robert’s day in court, to get the Medical Device Safety Act of 2009 passed into law.

We have since had a resolution with my son’s medical device manufacturer. I do not know if this medical device manufacturer would have filed a motion for preemption if we had gotten to court but I will continue this fight to get the Medical Device Act Passed.

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