Model Number MN10450-50A |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Undesired Nerve Stimulation (1980); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 03/17/2022 |
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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Event Description
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Related manufacturer reference number: 1627487-2022-01766.It was reported the patient experienced uncomfortable stimulation in the form of cramping.As a result one of the patients s1 leads was explanted and replaced to address the issue.It is unknown which lead was explanted so both are being reported.
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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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Search Alerts/Recalls
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