Model Number G160 |
Device Problems
High impedance (1291); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited an increase in right atrial (ra) lead pacing impedance that reached out of range measurements.Technical services (ts) was consulted and recommended testing options.This crt-d system remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited an increase in right atrial (ra) lead pacing impedance that reached out of range measurements.Technical services (ts) was consulted and recommended testing options.This crt-d system remains in service.No adverse patient effects were reported.Additional information was received and a spring contact issue is suspected.This crt-d system remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited an increase in right atrial (ra) lead pacing impedance that reached out of range measurements.Technical services (ts) was consulted and recommended testing options.This crt-d system remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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