Model Number U128 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient with this pacemaker stated that their remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, and a successful patient-initiated interrogation was sent.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.
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Manufacturer Narrative
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Correction: complaint does not meet report criteria.Mdr = no.Additional information was received which indicated the red call doctor icon was due to high impedances out of range in the right ventricular (rv) port.The patient was not implanted with an rv lead, only right atrial (ra) and left ventricular (lv) lead.Alerts will show up if they are not turned off in a port that does not have a lead connected.No evidence of device malfunction.This device remains in service and there were no adverse patient effects reported.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, and a successful patient-initiated interrogation was sent.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.
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Search Alerts/Recalls
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