Model Number 3058 |
Device Problems
High impedance (1291); Unable to Obtain Readings (1516); Connection Problem (2900); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a company representative regarding a patient who was implanted with a neurostimulator for urinary dys function/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that they just implanted a new lead and new implantable neurostimulator(ins).They were seeing question mark on c-3 and greater than 4000 ohms on all bipolar pairs except 2-3 (impedance ran at 2.V,390 pw).It was indicated that when they tested motor response with just the lead, they obtained response under 1v on all electrodes.Rep stated the set screw was misaligned in the header block so they had to untighten screw and retighten it, but when they screwed it in, the screw was clicking as if tighten all the way and the lead was still loose in the header block.It was indicated that the ins would need to be replaced as the screw would not tighten properly at this point.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information from the manufacturers' representative reported that the impedance issue resolved however; the cause was not determined.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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