Model Number DM3500 |
Device Problems
Failure to Capture (1081); Under-Sensing (1661)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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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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During follow-up, there was some false pause episodes due to the device undersensing and loss of capture noted on the device.No intervention was performed to resolve the event and the patient was in stable condition.
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Event Description
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During follow-up, there was some false pause episodes due to the device undersensing and loss of tissue contact.No intervention was performed as the event resolved after a few days, the healthcare professional believes the issue was related to pocked size during implant.The patient was in stable condition.
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Search Alerts/Recalls
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