Model Number 53401 |
Device Problems
Nonstandard Device (1420); Failure to Read Input Signal (1581)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: the epg failed a test related to the output control dial.It was found that the encoder for the control had a disconnected flex cable.The cable was reconnected.No other issues were identified.The device passed all final functional tests.Non-healthcare professional this device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The external pulse generator (epg) was returned as part of a field corrective action and subsequently tested out of specification.There was no patient involvement.
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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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