Other relevant device(s) are: product id: 37601, serial#: (b)(4) implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
|
A consumer reported the patient passed away on (b)(6) 2020 at a long-term care facility.The consumer was asked if the death was thought to be related to the device/therapy to which they stated ¿it could have been, the patient was under a lot of stress¿ due to having to get their implantable neurostimulator (ins) replaced so frequently over the last couple of years with the most recently replacement taking place on (b)(6) 2020.The consumer stated they couldn¿t say a ¿definite yes¿ that the death was related to the device/therapy and no autopsy was performed as they didn¿t ask for one, but the patient¿s ¿programming was set in a way they needed to have the battery changed.¿ when the patient needed replacement, they had a lot of appointments to get it approved which were difficult to get scheduled which started about six years ago.It was noted the patient was in a long-term care facility where they didn¿t provide ¿good therapy for the patient¿ and they stopped doing rehabilitation because ¿they¿ knew the patient had parkinson¿s and didn¿t think they would benefit from it.It was noted the patient was on a medication for their heart, amiodarone, and medication for their parkinson¿s, sinemet.The consumer stated there was no other relevant medical history for the patient and they didn¿t know if there were medical records leading up to the patient¿s death available.
|