Model Number 302-20 |
Device Problem
Disconnection (1171)
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Patient Problem
No Code Available (3191)
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Event Date 02/24/2015 |
Event Type
malfunction
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Event Description
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Analysis of the generator was completed.The pulse generator performed according to functional specifications.The battery showed an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 43.645% of the battery had been consumed.No performance or any other type of adverse conditions was found with the pulse generator.
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Event Description
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The explanted devices were received by the manufacturer on 04/20/2015.Analysis is underway, but it has not been completed to date.Analysis of the lead was completed.Scanning electron microscopy images of the connector pin show that the pitting or electro-etching conditions have occurred on the pin surface at the setscrew marks¿ location.No obvious adverse effect was identified on the device performance as a result of this condition.A portion of the lead including the electrode array was not returned for analysis, rendering an evaluation and resulting commentary on that portion of the lead impossible.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
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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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An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity.The lead impedance with the new system was within normal limits (1793 ohms).The explanted devices are expected to be returned for analysis, but have not been received to date.No additional relevant information has been received to date.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to a death or serious injury.
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Search Alerts/Recalls
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