Model Number MN10450-90A |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Migration (4003)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 09/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 1627487-2022-00567.It was reported the patient feels uncomfortable stimulation between the shoulder blades.Reprogramming was unable to resolve the issue.Surgical intervention may be pending to address the issue.
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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, patient and event information.
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Event Description
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Additional information was received indicating the pain was caused by lead migration.As a result, surgical intervention was undertaken wherein the leads were explanted and replaced to resolve the issue.
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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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