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 07/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.During processing of this complaint, attempts were made to obtain complete patient information.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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The external device displayed early replacement indicator.Troubleshooting is pending where the software will be updated.The device is providing therapy.
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Event Description
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Additional information received indicated updating the app version cleared the error message, resolving the issue.
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Search Alerts/Recalls
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