Model Number F102 |
Device Problems
Device Alarm System (1012); Premature Discharge of Battery (1057)
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Patient Problem
Anxiety (2328)
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Event Date 12/04/2021 |
Event Type
Injury
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.
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Manufacturer Narrative
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The returned implantable cardioverter defibrillator was analyzed and it was confirmed that the device recorded code 1003.An engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Boston scientific has concluded that this device experienced normal battery depletion.
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.It was additionally reported that the device was replaced.Boston scientific has received the device for analysis.
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.It was additionally reported that the device was replaced.Boston scientific has received the device for analysis.
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Search Alerts/Recalls
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