Model Number 304-20 |
Device Problem
Use of Incorrect Control/Treatment Settings (1126)
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Patient Problems
Twitching (2172); Neck Pain (2433)
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Event Date 01/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Suspect device udi#: (b)(4).
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Event Description
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It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet.The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use.Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching.No settings were changed due to the reported muscle twitching.
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Event Description
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The patient underwent vns explant surgery.During attempts at product return, it was revealed that the facility, historically, does not return explanted products.
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Manufacturer Narrative
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Describe event or problem, corrected data: follow-up report #1 inadvertently left out information.(b)(4).
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Event Description
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Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted.It was stated that she developed issues with tension at the neck when trying to do sit-ups.When the vns activated, she experienced contractions of the laryngeal musculature.The patient reported twitching in her neck muscles with magnet stimulation.The vns magnet mode was programmed off.It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before.The operative notes from the initial implant were included and no complications were reported.It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.
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Search Alerts/Recalls
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