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 12/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.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 displayed an elective replacement indicator (eri) message prematurely.In turn, a wireless software update was performed clearing the message.The device is still providing therapy.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient information.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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