The main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a healthcare professional (hcp) via manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor.It was reported the lead migrated through the lumen of the stomach.It was unknown if there were environmental, external, or patient factors that led or contributed to the issue.The rep stated the only know diagnostic was an esophagogastroduodenoscopy (egd).The rep noted the hcp requested the device be shut off and the patient to be scheduled for a lead revision.It was unknown if the issues were resolved at the time of the report.The hcp noted that surgical intervention did not occur, but it was planned, but had not been scheduled.The patient was listed as alive with no injury at the time of the report.There were no further complications that have been reported as a result of this event.
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