Model Number G124 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient has complete heart block felt it whenever there is threshold testing.Boston scientific technical services (ts) discussed that the device has reached battery capacity depleted (bcd) and uncertain if device has exhibited premature battery depletion (pbd) unless device is returned to the laboratory for testing and recommended immediate replacement.The device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that the patient has complete heart block felt it whenever there is threshold testing.Boston scientific technical services (ts) discussed that the device has reached battery capacity depleted (bcd) and uncertain if device has exhibited premature battery depletion (pbd) unless device is returned to the laboratory for testing and recommended immediate replacement.The device remains in service.No adverse patient effects were reported.Additional information received indicating that the device was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed and 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.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
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Event Description
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It was reported that the patient has complete heart block felt it whenever there is threshold testing.Boston scientific technical services (ts) discussed that the device has reached battery capacity depleted (bcd) and uncertain if device has exhibited premature battery depletion (pbd) unless device is returned to the laboratory for testing and recommended immediate replacement.The device remains in service.No adverse patient effects were reported.Additional information received indicating that the device was explanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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