Percept ins is not approved in us at this time, but is similar to devices approved under mhy. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient was experiencing electrical sensations around the ins site. After implant the impedance measurements were all normal, but one day later the sensations began and impedance was measured to be 40 ohms too high, slightly out of range. No true troubleshooting had been performed other than several impedance checks. The cause was not definitively determined, but it was stated there was "probably some fluid within the ins and extension. " a revision surgery to de- and reconnect the extension and ins was proposed, but the sensations had been becoming weaker. The patient decided to wait some days/weeks and if there was further improvement, no revision would be performed.
Patient Sequence No: 1, Text Type: D, B5