It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted.She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes.The patient also stated that the generator moves when she moves her arm.She was looking to receive a smaller generator as the m103 generator gave her no issues.Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator.It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration.Attempts were made for follow-up with the psychiatrist's office.It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available.It could not be clarified if a model 103 device or model 105 device was implanted.It was stated that the patient was scheduled for explant surgery due to the reported events.No further relevant information was received to date.
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It was clarified that the patient had a vns replacement in 2015 to the larger m105 device.Due to the discomfort the patient was feeling, the device was removed in early september, stated to be due to the need for a mammogram.No further information was received to date.
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