Model Number U128 |
Device Problems
Premature Discharge of Battery (1057); False Positive Result (1227)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has been returned for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker exhibited a signal artifact monitor episode resulting in the respiratory rate trend sensor being disabled.Technical services noted this was due to the false positive detection of atrial fibrillation.The healthcare provider questioned if the battery of this pacemaker was depleting prematurely.A request was made to have data from this device analyzed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that the battery appeared to be depleting more quickly than expected.The device was explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker exhibited a signal artifact monitor episode resulting in the respiratory rate trend sensor being disabled.Technical services noted this was due to the false positive detection of atrial fibrillation.The healthcare provider questioned if the battery of this pacemaker was depleting prematurely.A request was made to have data from this device analyzed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed that the battery appeared to be depleting more quickly than expected.The device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.
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Search Alerts/Recalls
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