Model Number 3660 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2017 |
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 (b)(6) 2017.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.Concomitant medical products and therapy dates unknown.
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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 device has the appropriate level of battery voltage to provide therapy.
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Event Description
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Additional information identified that ipg was functioning properly.
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Search Alerts/Recalls
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