In a recent review of the FDA Maude Database, we found a very unusual report sharing the death of a patient that may have been related to battery acid leaking from their Interstim device. The report says:
“It was reported the patient died on (b)(6) 2013 due to ¿acid leakage and parkinson’s. It was stated the patient had parkinson’s stage three and they fell down the stairs while walking their dog and the patient went to a rehab facility after the fall. The patient did not do her leg exercises at the rehab facility, so her legs ¿atrophied¿ and she could not get out of bed. By lying in bed she became stiff from parkinson’s and lost weight from not eating and having a poor appetite. It was stated the battery packs that were in her, ¿the acid started leaking and created holes in her kidneys. ¿ when the patient fell in 2013, she weighed (b)(6) pounds and at her death in (b)(6) 2013, she weighed (b)(6) pounds. The caller wanted to donate the programmer.”
What is particularly frustrating about the MAUDE database reporting process is that follow up information is rarely provided nor can we see if additional investigation has or is occurring. Could the battery have been damaged during a fall?? Could it have been a device failure? We believe that an independent panel should be convened to review the fatalities and severe adverse events reported with this device.
This report was filed on 06/07/13. The patient outcome was “Death.”