Model Number 302-20 |
Device Problem
Fracture (1260)
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Patient Problems
Dyspnea (1816); Pain (1994); Seizures (2063)
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Event Date 09/10/2018 |
Event Type
malfunction
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Event Description
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It was reported that upon interrogation this patient's device was showing near end of services (neos) = yes and high impedance.The patient has been referred for surgery.Clinic notes were received for this patient's replacement due to high impedance which indicated that the patient is showing decreased battery life and abnormal lead impedance as well as recurrent seizures.The patient reports electrical pain with head turning left.And therefore the vns was reprogramed to reduce pulse width.The patient also feels shortness of breath intermittently every couple days with the vns going off.No known surgical intervention has occurred to date.No other relevant information has been received to date.
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Manufacturer Narrative
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Explant date, corrected data: supplemental report #1 inadvertently listed a date for the explant date.The suspect device was not explanted at that time.
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Manufacturer Narrative
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Adverse event or product problem, corrected data: initial report inadvertently did not list adverse event.Outcomes attributed to adverse event, corrected data: initial report inadvertently did not check "required intervention to prevent permanent impairment/damage".
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Event Description
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It was reported that this patient received a generator replacement.The lead impedance was ok at the time of surgery when the generator was replaced.The explant facility was stated to be a no return site per the or staff.No other relevant information has been received to date.
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Search Alerts/Recalls
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