Model Number 3662 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/14/2020 |
Event Type
malfunction
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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.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.
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Event Description
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It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The wireless software update was performed clearing the eri message.The device is providing therapy.
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Manufacturer Narrative
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An elective replacement indicator message was reported to abbott.The results of the investigation are inconclusive since the device nor logs or records were returned for analysis.Actions have been taken to prevent reoccurrence.
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Search Alerts/Recalls
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