Model Number 304-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2016 |
Event Type
malfunction
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Event Description
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It was reported by a medical professional to a company representative that a vns patient¿s device has high lead impedance.The impedance value was noted to be high.It was provided the patient did not have any side effects as a result.The impedance value at surgery was within normal limits.The patient was referred for lead revision.During surgery, the surgeon opened the pocket and noticed the lead pin was not fully tightened into the generator.The surgeon used fluoroscopy to examine the lead and did not find anything abnormal.The lead impedance was then tested and was within normal limits.The surgeon then properly inserted and tightened down the lead and the lead impedance was within normal limits again.The patient was closed and the generator was turned back on to the most recent settings.Additional relevant information has not been received to-date.
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Event Description
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Follow-up from the company representative provided that the patient¿s device is showing high lead impedance still.It was stated that there has not been any trauma or manipulation.X-rays were reported to have been taken by the physician and they stated there were no apparent issues.It was stated that lead impedance was high, when the patient was sitting down, standing up, and laying down.The patient was referred for revision surgery.No known surgery has occurred to-date.
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Event Description
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Lead revision surgery occurred and the explanted device was received by the manufacturer on (b)(6) 2017.Analysis is underway, but 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 returned lead portion (b)(6) 2017.The electrodes were not returned for analysis and a complete evaluation could not be performed on the entire lead product.During the visual analysis what appeared to be rust like deposits were observed on the connector pin surface.Scanning electron microscopy was performed and identified evidence of rust like deposits and pitting on the connector pin surface.A definite cause for the pitting could not be determined based on the lead portion returned.The condition of the returned lead portion is consistent with that which typically exists following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, and no discontinuities were identified.There is no evidence to suggest discontinuities in the returned portion of the device.
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Search Alerts/Recalls
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