Model Number CD3231-40 |
Device Problems
Defective Alarm (1014); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/22/2019 |
Event Type
Injury
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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.Further information was requested but not received.
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Event Description
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It was reported that the patient presented in clinic for a follow up.The vibratory alert was found to not be working.Issues with the remote monitoring device were also noted.Since the patient is pacemaker dependent, a prophylactic generator explant due to the advisory was discussed.
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Manufacturer Narrative
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Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).
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Event Description
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New information received notes that the device was explanted and replaced.Patient was stable throughout the procedure.
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Search Alerts/Recalls
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