Model Number 101 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/02/2001 |
Event Type
malfunction
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Event Description
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Analysis of the returned lead portion was completed.The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.There were no other product-related issues observed.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
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Manufacturer Narrative
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Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
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Event Description
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It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the vns patient¿s replacement generator was tested with the existing lead and showed high impedance.The lead pin was reinserted into the generator header and the high impedance condition had resolved.Abrasions were noted on the patient¿s lead.The surgeon elected to replace the lead during the procedure.Pre-operative diagnostics did not reveal any issues.The explanted devices were returned to the manufacturer for analysis.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.Analysis of the returned lead portion is currently underway.
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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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Age at time of event; corrected data: the initial mdr inadvertently did not provide the correct patient age.Date of event; corrected data: the initial mdr inadvertently did not provide the correct event date.Brand name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event.Type of device, name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event.Model #, serial #, lot#, expiration date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event.Operator of device; corrected data: the previously submitted mdr inadvertently did not provide the correct operator of the device for the event.Device manufacture date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event.Evaluation codes, methods, results, conclusions; corrected data: the previously submitted mdr's inadvertently did not provide the correct evaluation coding for the event.Additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently stated a device failure was suspected.
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Search Alerts/Recalls
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