Model Number 3660 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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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Event Description
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It was reported that the patient's ipg was explanted and replaced on (b)(6) 2020.The patient still had therapy before explant.Patient has therapy post operatively.
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Manufacturer Narrative
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This issue is no longer reportable.
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Event Description
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Additional information was provided that indicates that the patient did not lose stimulation and was previously inadvertently reported on.
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Search Alerts/Recalls
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