Model Number 24970A |
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 12/12/2019 |
Event Type
malfunction
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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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It was reported that when using the mobile programmer to test lead impedance range for pacemaker implantation procedure, it displayed abnormally high measurements.Troubleshooting steps were unsuccessful and the user deployed a different programmer model which recorded normal impedance readings.The mobile programmer remains in the field and the issue has been escalated for further investigation.There were no patient symptoms or complications associated with this event.
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Manufacturer Narrative
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Product analysis: analysis of the device logs was able to confirm there was a problem obtaining the impedance measurement due to a software issue.The software issue has been addressed in subsequent software update releases.If information is provided in the future, a supplemental report will be issued.
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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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