Model Number MN10450-50A |
Device Problem
High impedance (1291)
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Patient Problem
Convulsion/Seizure (4406)
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Event Date 03/12/2023 |
Event Type
Injury
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Event Description
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Related manufacturer report number: (b)(4).It was reported that the patient was experiencing unexpected shocking, causing their leg to jump and two of their leads were autoreducing.It was noted that all three leads had high impedances.X-ray revealed that the patient's l1 lead had migrated.As a result, the patient may undergo surgical intervention to address the issue.
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Manufacturer Narrative
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Date of event is estimated.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Additional information received indicates that the patient underwent surgical intervention during which the 3 leads were explanted and replaced, resolving the issue.
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Search Alerts/Recalls
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