Model Number 3341 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Date 01/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.Event date is an estimation.
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Event Description
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Related manufacturer reference number: 1627487-2020-02548.Related manufacturer reference number: 1627487-2020-02549.Related manufacturer reference number: 1627487-2020-02550.Related manufacturer reference number: 1627487-2020-02551.It was reported that the patient's system was explanted on an unknown date in 2016 due to uncomfortable stimulation in the patient's feet.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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