Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Paralysis (1997)
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Event Date 10/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete event.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: 3006705815-2020-32394 and 3006705815-2020-32396.It was reported that the patient woke up and could not feel or move their legs.The patient was advised by their physician to turn therapy off.A stat mri was ordered for the patient but the patient¿s fever spike before the mri could be started.The patient was airlifted to a different facility where the scs system was explanted, the exact date is unknown.The patient is currently in a rehab facility recovering.
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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.
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Event Description
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Related manufacturer reference number: 3006705815-2020-32394, 3006705815-2020-32396, 1627487-2020-47874, and 1627487-2020-47875.
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Event Description
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Related manufacturer reference number: 3006705815-2020-32394, 3006705815-2020-32396, 1627487-2020-47874, and 1627487-2020-47875.
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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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