Model Number PM2272 |
Device Problem
Telemetry Discrepancy (1629)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that prior to implant procedure, it was noted that the pacemaker's wireless telemetry would not turn on and was not working.Another telemetry wand was attempted without success.The device was replaced.There was no patient involvement.
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Manufacturer Narrative
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The reported event of a radio frequency (rf) communication anomaly was confirmed.The device was received with no rf communication.Device image analysis indicated average monthly voltage and current trends were normal.Product code was reloaded, and rf functionality was restored.Despite extensive testing, disabling of rf telemetry could not be reproduced.
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Search Alerts/Recalls
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