Information references the main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.
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The health care provider (hcp) reported that the patient had idiopathic gastroparesis with gastric stimulator placement, revision, and then failure.Recently the patient was having difficulties and the system was interrogated.It showed a resistance in the system of greater than 800 ohms, which suggested a break in the system.The hcp met with the patient and they elected to proceed with replacement.The patient had a gastric stimulator replacement including the leads on (b)(6) 2016.The resistance in the system was approximately 540 ohms after replacement and it was set to the nominal settings.The patient also had an upper gastrointestinal endoscopy.There were no complications and the patient tolerated the procedure well.
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