Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 12-jun-2016, udi#: (b)(4).Product id: 4351-35, serial/lot #: (b)(4), ubd: 12-jun-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a consumer (con) and from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that about 4 months ago, the patient¿s symptoms started getting worse and the patient knew they were at the highest level.It was noted that the implant was ¿not working¿ and the battery had ¿died¿; it was then reported that the patient was not sure if the battery had died yet.It was noted that the patient had an immune disorder and didn't want to have surgery if they didn't need to remove the battery when it is dead, and they were thinking about getting a feeding tube.The patient would be seeing their doctor on (b)(6) 2018.On (b)(6) 2018, the hcp reported that the battery was fine, but the leads were loose.No further complications were reported/anticipated.
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Additional information received from a healthcare professional (hcp).It was reported that the patient had a fall and their problems increased after that.The patient was taken to the operating room (or) and the leads were detached, reattached, and tightened with good effect.
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