Model Number DM3500 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that an implantable cardiac monitor displayed an error message on (b)(6) 2020 before an implantation surgery.Device was exchanged for another one and surgery was completed successfully on (b)(6) 2020.Patient had no consequences as a result of the event.
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Manufacturer Narrative
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Final analysis found a junco integrated circuit anomaly which resulted in voltage at end of life level, high current drain, and failure to establish ble communication.
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Search Alerts/Recalls
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