Model Number CD3371-40C |
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 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.(b)(4).
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Event Description
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During follow up, after an alert from a patient notifier, high voltage lead impedance was noted to be out of range.Other electrical parameters were within normal range.The patient was hospitalized for observation and further review of the system.
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Event Description
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During follow up, after an alert from a patient notifier, high voltage lead impedance was noted to be out of range.Other electrical parameters were within normal range.The physician opened the pocket and reconnected the rv coil (medtronic) and the lead impedance was stable and within range.
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Search Alerts/Recalls
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