Continuation of medical devices: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 13-jul-2017, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 13-jul-2017, 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 regarding a patient.It was reported that the patient was hit in the stomach, right in the gastrostomy tube, which caused the leads to go through the stomach and they got an infection.The infection was confirmed, and the patient received iv antibiotics, as they had a peripherally inserted central catheter (picc) line with harsh medicine.The consumer stated that it was a great device that worked for the patient, but they could not run and play because it was a fragile device.The consumer also reported that the patient had three gastric devices implanted and their body was not accepting the devices.It was noted that the infection occurred maybe three years prior to the date of this report.Additionally, the consumer reported that the patient¿s gastroparesis was getting worse.No further complications were reported or anticipated.Indications for use are gastric stimulation and gastrointestinal/pelvic floor.
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