Patient information was not provided for reporting.Date of event was reported as (b)(6) 2017.However, it is unknown if the device malfunctioned on the date or if the malfunction was detected on the date.(b)(4).Date of implant is unknown.It was not reported if the explant procedure was planned or completed.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device history records review was completed for part# 460.010.01s, lot# l276409.Manufacturing location: (b)(4), manufacturing date: jan 24, 2017, expiry date: jan 01, 2027.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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