Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).Pertain to product id: 435135, serial#: (b)(4), product type: lead.And product id: 435135, serial#: (b)(4), product type: lead.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 a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that approximately a year ago, the patient started complaining of pain and loss of therapy and the hcp adjusted the patient¿s settings at that time.It was noted that somewhere in the last year, the patient¿s impedance started reading out of range, and on the day of the report, the hcp discovered that the previous surgeon had placed too much of the leads into the pocket, shortening the leads, and pulling the stomach upwards toward the skin.The hcp also discovered one of the leads had pulled away from the stomach and it was causing the impedance issue (c & 3 was greater than 4000).The hcp also discovered a hernia underneath the battery pocket that was causing the patient severe pain; the hernia was repaired and both leads and the battery were removed and replaced with new ones.It was unknown what factors may have led or contributed to the issue.It was noted that the issue was resolved at the time of the report.No further complications were reported/anticipated.
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