Model Number G125 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2020 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) triggered red call doctor icon on the communicator due to mutiple high out-of-range pace impedance measurements greater than 2,000 ohms on the right ventricular (rv) lead since (b)(6) 2020.The patient was referred to the clinic for further evaluation.This crt-d system remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) triggered red call doctor icon on the communicator due to mutiple high out-of-range pace impedance measurements greater than 2,000 ohms on the right ventricular (rv) lead since (b)(6) 2020.The patient was referred to the clinic for further evaluation.This crt-d system remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.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 product performance issue 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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Search Alerts/Recalls
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