Model Number 37800 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/09/2017 |
Event Type
Injury
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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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Event Description
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A manufacturing representative (rep) reported a patient came in for their routine adjustment and an impedance was found out of range.The hcp was going to order an x-ray and egd to determine if the leads had migrated.No further complications were reported/anticipated.
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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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Event Description
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Additional information was received from a manufacturer representative.It was reported that the device was explanted and a new device was implanted.No further complications were reported/anticipated.
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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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Event Description
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Additional information was received from a manufacturer representative.It was reported that the cause of the leads being out of range was not determined.No further complications were reported/anticipated.
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Search Alerts/Recalls
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