Model Number 302-20 |
Device Problem
Battery Problem: High Impedance (2947)
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Patient Problem
Chest Pain (1776)
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Event Date 03/12/2015 |
Event Type
malfunction
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Event Description
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It was reported that device diagnostics resulted in high impedance.The patient reported pain in the chest area during device stimulation.The device was programmed off after observing the high impedance.The patient was referred for x-rays.The patient has been referred for surgery.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.
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Event Description
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It was reported that the patient underwent lead and generator replacement on (b)(6) 2015.It was reported that a keloid had developed around the explanted lead.The generator was replaced prophylactically.It was reported that the explanted lead was discarded.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.The explanted devices have not been returned to date.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Manufacturer Narrative
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Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Adverse event or product problem; corrected data: the previously submitted mdr inadvertently provided incomplete information, as it did not specify that the event was both an adverse event and product problem.Outcomes attributed to adverse event; corrected data: the previously submitted mdr inadvertently provided incomplete information.
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Search Alerts/Recalls
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