Model Number 3660 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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This report is related to a (b)(6) patient.It was reported the patient underwent shoulder surgery following a fall.Prior to the procedure the patient did not program their ipg into surgery mode.In turn, their ipg was deemed inoperable following the surgical procedure.As a result, the patient plans to undergo surgical intervention to address their inoperable ipg issue.
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Manufacturer Narrative
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The reported observation of ¿ipg communication issue¿ was confirmed.The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state.The root cause of the device entering the service application state was due to the patient¿s unrelated surgical procedure as stated in the event details.There is guidance noted in the clinicians manual concerning handling of the device: electrosurgery devices should not be used in close proximity to an implanted neurostimulation system.
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Event Description
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Additional information gathered via follow-up revealed the patient's ipg was explanted and replaced.Surgical intervention addressed the patient's issue.
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Manufacturer Narrative
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Corrected data: device available for evaluation (the return date on the previous follow-up report was deemed incorrect following further review).
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Search Alerts/Recalls
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