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 02/27/2014 |
Event Type
malfunction
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Event Description
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It was reported that device diagnostics resulted in high impedance.The generator was programmed off and the patient was referred for x-rays.The patient may be referred for surgery.No known surgical intervention has been performed to date.
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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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The previously submitted mdr inadvertently provided the wrong evaluation codes.
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Event Description
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It was reported that through the programming history database periodic review high impedance occurred on vns patient's generator model 102 serial number (b)(4).
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Manufacturer Narrative
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Manufacturer reviewed x-rays of implanted device.
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Event Description
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X-rays dated on (b)(6) 2015 were provided to the manufacturer for further review.The generator appears in the right chest in an abnormal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
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Manufacturer Narrative
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The previously submitted mdr inadvertently provided an incorrect gender.The previously submitted mdr inadvertently provided an incorrect event date.The previously submitted mdr inadvertently provided an incorrect event description.The previously submitted mdr inadvertently provided an incorrect data.
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Event Description
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The available programming history data of the patient¿s device (model 102 sn (b)(4)) was reviewed.The data was observed from (b)(6) 2013 through (b)(6) 2014.The device was last programmed on (b)(6) 2014 to 8% duty cycle.The last parameters recorded were 0 ma/20hz/250¿s/21sec/5min and magnet mode was1.25 ma/21sec/250¿s.Diagnostic data was also found.Last diagnostic recorded was on (b)(6) 2014.The lead impedance was high (dcdc 7) and eri no.The parameters data also indicated that the stimulation ok.The review of the available programming history revealed high impedance observed on (b)(6) 2014.
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Search Alerts/Recalls
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