Model Number 3660 |
Device Problem
Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of the event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2020-49306, 1627487-2020-49307.It was reported the patient had their system explanted on (b)(6) 2020 for an unknown reason.
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Manufacturer Narrative
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There was no specific complaint concerning device performance therefore the observation was not confirmed.The device exhibited normal device characteristics throughout analysis.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.
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Search Alerts/Recalls
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