Model Number 103 |
Device Problems
Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Pain (1994); Seizures (2063); Inadequate Pain Relief (2388); No Information (3190)
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Event Date 01/10/2013 |
Event Type
Injury
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Event Description
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It was reported by the surgeon the patient was going to have her vns explanted on (b)(6) 2016.The surgeon stated the patient had been implanted for over 3 years and the vns was not effective because the patient wasn't able to tolerate titrating up the vns settings.Attempts for additional relevant information have been unsuccessful to date.
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Event Description
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It was later reported the patient had requested for the device to be explanted because she didn't like it and it wasn't helping her.It was noted the device was programmed off because the patient didn't like the current, but then she just didn't like the vns.There were no issues with the vns, the patient just did not like it and requested the explant.It was later verified the patient's vns was explanted on (b)(6) 2016.
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Manufacturer Narrative
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This information was inadvertently left off of the supplemental #01 mfr.Report.(b)(4).
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Event Description
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It was later reported by the same physician that the adverse events the patient experienced during titration included pain in the neck, difficulty swallowing, uncomfortable when the current is programmed on, increased falls during her seizures, and no decrease in seizures activity.It was also noted that the patient's seizures were possibly worse with vns; however, no actual seizure rates were given.
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Event Description
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It was reported by the explanting facility that the device was discarded.
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Manufacturer Narrative
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This information was inadvertently left off of supplemental #03 mfr.Report.
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Event Description
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It was initially reported by the explanting site that the vns devices had been discarded; however, additional information was received from the site and they had requested the return number so that they could send the generator back.The generator and a portion of the lead were returned to the manufacturer.While analysis is expected, it 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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Product analysis (pa) for the returned generator was completed.The device performed per functional specifications.There were no performance or any other type of adverse conditions found with the generator.Pa for the returned lead was completed.Note that the lead assembly (body) including a portion of the connector boot; therefore, a complete evaluation could not be performed on the entire lead product.The condition of the returned portion of the lead was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.
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Search Alerts/Recalls
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