Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Code Available (3191)
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Event Date 07/29/2015 |
Event Type
malfunction
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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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Event Description
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On (b)(6) 2015 it was reported that the patient has high impedance on both normal mode and system diagnostics that was found on (b)(6) 2015; lead impedance-high/output-limit.There was no trauma to the area and the physician stated that there were no apparent causes.She referred the patient for revision surgery.The physician reported that x-rays were not taken.Although surgery is likely, it has not occurred to date.
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Event Description
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It was later reported on (b)(6) 2015 that x-rays were ordered.They have not been received for review by the manufacturer to date.
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Event Description
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A copy of the patient's x-rays were received for review.The filter feedthru wires were intact.The connector pin does not appear to be fully inserted inside the connector block, as the pin was not visualized to pass completely through the connector block.The lead wire was intact at the location of the connector pin; however there was a portion of the lead located behind the generator that could not be assessed.There did not appear to be any lead discontinuities in the portion of the lead that could be visualized near the generator.The electrode placement was performed as per labeling.Strain relief is present but is not per labeling as there is no strain relief loop.Three tie downs appear to be present.There were no obvious discontinuities with the lead; however, a micro-fracture in the lead cannot be ruled out.
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Event Description
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It was reported that the patient was referred for exploration surgery to try and reinsert the lead pin into the generator.Although surgery is likely, it has not occurred to date.
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Manufacturer Narrative
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If follow-up, what type; corrected data: the suspect medical device should have been changed to the model 105 generator serial number (b)(4) on follow-up report #2 but it wasn't changed until follow-up report #3.Therefore, follow-up report #3 should have been marked as a correction mdr for section.
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Event Description
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On (b)(6) 2016 it was reported that during pre-op for the surgery for the patient, he checked the patient's device and received high impedance, >10,000ohms, and the battery was completely full.They took the patient into surgery and opened up the pocket.The surgeon was able to see that the leads were not all the way in, so he took it out and put it back in making sure that the pins were in and the setscrew was tightened till it clicked.Then when they did the diagnostics, the impedance was all fine, however now has a message stating battery is near eos (neos=yes) and the battery icon only has a small line of red showing.Electrocautery was used to open up the pocket.Therefore, the generator was replaced as well.
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Search Alerts/Recalls
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