Model Number 3660 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/ method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient's ipg was unable to connect with external devices.The device was deemed inoperable, confirmed by the "generator has reached its end of service" message.In turn, surgical intervention may take place to address the issue.
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Event Description
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Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted and replaced, resolving the issue.
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Manufacturer Narrative
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Evaluation codes - changed device code to reflect normal eol.The reported inoperable ipg was confirmed.It was determined the device declared elective replacement indication (eri) and end of life (eol).The cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).
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Search Alerts/Recalls
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