Model Number DM3500 |
Device Problems
Failure to Capture (1081); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Further information was requested but not received.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 a clinic follow-up, a loss of capture was observed on the device.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
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Manufacturer Narrative
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The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.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 a clinic follow-up, redness and itchiness of the device pocket was observed.Additionally, the patient presented with a fever and a loss of contact with the tissue was observed on the device.A loss of capture was not observed on the device.The device was explanted and replaced as a result of the infection.Furthermore, the infection was resolved with antibiotics.The patient was stable.
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Search Alerts/Recalls
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