Model Number CD3231-40Q |
Device Problems
Premature Discharge of Battery (1057); Difficult to Interrogate (1331)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/09/2018 |
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.
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Event Description
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It was reported that when patient presented in clinic, upon device interrogation telemetry wireless communication issue was observed.Device was interrogated with two programmers however the device was unable to be interrogated.Upon device interrogation prior to the surgery device was able to be interrogated.The device is under battery performance alert (bpa) advisory however there were no bpa alerts.Physician suspected that the device may have experienced bpa related drop in voltage and deemed the device to be unreliable and therefore opted for device change out procedure.Patient had symptoms of feeling tired more than usual however no syncope was experienced and the patient is not pacemaker dependent.Device was explanted and a new device was implanted.Patient was stable prior, during and post procedure.
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Manufacturer Narrative
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The reported event of premature depletion and intermittent communication could not be confirmed in the lab.Interrogation of the device revealed the device was above the elective replacement indicator when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The cause of the field event remains undetermined.
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Search Alerts/Recalls
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