Model Number 3660 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/17/2021 |
Event Type
Injury
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Event Description
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It was reported the patient had an unrelated procedure where it is unknown if the device was set to surgery mode or not.In turn, the ipg became inoperable.Troubleshooting is pending.
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Manufacturer Narrative
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The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.
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Event Description
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Additional information received indicates that the patient underwent surgical intervention during which the ipg was explanted and replaced with no complications.
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Search Alerts/Recalls
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