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///Interstim FDA Report – Battery Acid Leakage May Have Contributed to Patient Death

Interstim FDA Report – Battery Acid Leakage May Have Contributed to Patient Death


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.”

See the report here!

By |2017-01-31T13:22:54+00:00January 27th, 2014|Consumer Alerts, News|Comments Off on Interstim FDA Report – Battery Acid Leakage May Have Contributed to Patient Death

About the Author:

My Google Profile+ Jill Heidi Osborne is the president and founder of the Interstitial Cystitis Network, a health education company dedicated to interstitial cystitis, bladder pain syndrome and other pelvic pain disorders. As the editor and lead author of the ICN and the IC Optimist magazine, Jill is proud of the academic recognition that her website has achieved. The University of London rated the ICN as the top IC website for accuracy, credibility, readability and quality. (Int Urogynecol J - April 2013). Harvard Medical School rated both Medscape and the ICN as the top two websites dedicated to IC. (Urology - Sept 11). Jill currently serves on the Congressionally Directed Medical Research Panel (US Army) where she collaborates with researchers to evaluate new IC research studies for possible funding. Jill has conducted and/or collaborates on a variety of IC research studies on new therapeutics, pain care, sexuality, the use of medical marijuana, menopause and the cost of treatments, shining a light on issues that influence patient quality of life. An IC support group leader and national spokesperson for the past 20 years, she has represented the IC community on radio, TV shows, at medical conferences. She has written hundreds of articles on IC and its related conditions. With a Bachelors Degree in Pharmacology and a Masters in Psychology, Jill was named Presidential Management Intern (aka Fellowship) while in graduate school. (She was unable to earn her PhD due to the onset of her IC.) She spends the majority of her time providing WELLNESS COACHING for patients in need and developing new, internet based educational and support tools for IC patients, including the “Living with IC” video series currently on YouTube and the ICN Food List smartphone app! Jill was diagnosed with IC at the age of 32 but first showed symptoms at the age of 12.