Model Number MN10450-90A |
Device Problems
High impedance (1291); Migration (4003)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 02/21/2024 |
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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It was reported that the patient was experiencing ineffective therapy from their system.X-rays confirmed that 3 of the leads had migrated and one lead had high impedance.In turn, surgical intervention may take place to address the issue.
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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 revealed that the patient underwent surgical intervention wherein the leads were explanted and replaced.Postoperatively, the patient has effective therapy.
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Search Alerts/Recalls
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