Model Number DM2102 |
Device Problems
Inappropriate or Unexpected Reset (2959); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Further information was requested but not received.
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Event Description
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During a clinic follow-up, the device was found in back-up mode following a mri procedure.Reprogramming of the device is anticipated but no further intervention has been performed.The patient was stable and will continue to be monitored.
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Manufacturer Narrative
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Correction: upon review, the implantable cardiac monitor should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
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Event Description
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Additional information received indicated the backup mode was due to the device reaching normal end of life (eol).
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Search Alerts/Recalls
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