Model Number 3662 |
Device Problems
Premature End-of-Life Indicator (1480); No Apparent Adverse Event (3189)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/19/2019 |
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 patient received 'replace generator soon' message.At time of visit with rep the message was cleared, however it then returned.Surgical intervention may be taken at a later date to address the issue.
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Manufacturer Narrative
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The device was not returned for analysis; however, logs and/or assessment report were assessed and indicate that the battery voltage level of the device is within specifications to trigger the eri indicator.Based on the information received, the cause of the reported incident is consistent with the battery nearing normal end of life.
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Event Description
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It was reported that the old ipg was explanted and a new ipg implanted.No reported complications.Therapy reportedly was restored.
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Search Alerts/Recalls
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