Model Number 6660 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain weight but not received.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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A system displaying the ¿replace generator soon¿ warning message was reported to abbott.The software was updated and the error message was cleared.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 event could not be conclusively determined.
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Search Alerts/Recalls
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