Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problem
Dysphasia (2195)
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Event Date 04/19/2014 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value = 10,000 ohms).The neurologist suspected fibrosis was causing high impedance as the patient was experiencing voice hoarseness with normal mode stimulation every five minutes.The patient was referred for generator and lead replacement surgery but no known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.
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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.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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Electronic submission of this report was not possible due to a problem with the manufacturer's software used for emdr submissions.
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Event Description
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It was reported that the patient had generator and lead replacement on (b)(6) 2014.The surgeon reported that there appeared to be corrosion on the lead.The explanted products were received by the manufacturer for analysis.However, analysis has not been completed to date.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Analysis was completed on the generator and lead.The surgeon stated that the lead appears corroded.It was presumed the surgeon meant the (-) unmarked connector pin returned inserted into the cavity of the generator.The (-) unmarked connector boot and inner silicone tubing were cut to expose the surface of the (-) connector pin.The (-) unmarked connector pin appeared to be partially covered in what appeared to be remnants of dried body fluids and did not appear to be adhered to the inside of the connector boot.However, there was a presence of dried adhesive observed on the inside of the (-) connector boot.The (-) unmarked connector pin was cleaned.After the cleaning process the surface of the (-) connector pin did not appear to be corroded.What the surgeon thought to be corrosion appeared to have been remnants of dried body fluids which most likely leaked in between the (-) unmarked connector pin and connector boot through the detached area.During the visual analysis the (+) marked connector quadfilar coil appeared to be broken approximately 87mm and 92mm from the end of the connector bifurcation.Scanning electron microscopy (sem) was performed on the (+) marked connector quadfilar coil break (found at 87mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage.Sem was performed on the (+) marked connector quadfilar coil break (found at 92mm) and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.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.The generator performed according to functional specifications in the analysis lab.
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Search Alerts/Recalls
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