Model Number G125 |
Device Problems
Failure to Capture (1081); High impedance (1291); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2023 |
Event Type
malfunction
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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 this system with a cardiac resynchronization therapy defibrillator (crt-d) and a non-bsc left ventricular (lv) lead triggered an alert for lv automatic threshold test.It appeared that the test had not been able to be run for various days, nonetheless, when the crt-d was analyzed, it was no longer in suspension mode.The impedance values had increased as well and several months ago the behavior had been unstable.Also, failure to capture was observed for the lv lead.Before the high, out of range pacing impedances the presenting electrogram appeared different and the lead was capturing.A lead fracture was suggested, and the health care professional agreed.The crt-d and the lv lead remain in service.No symptoms or 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 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.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 this system with a cardiac resynchronization therapy defibrillator (crt-d) and a non-bsc left ventricular (lv) lead triggered an alert for lv automatic threshold test.It appeared that the test had not been able to be run for various days, nonetheless, when the crt-d was analyzed, it was no longer in suspension mode.The impedance values had increased as well and several months ago the behavior had been unstable.Also, failure to capture was observed for the lv lead.Before the high, out of range pacing impedances the presenting electrogram appeared different and the lead was capturing.A lead fracture was suggested, and the health care professional agreed.The crt-d and the lv lead remain in service.No symptoms or adverse patient effects were reported.
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Search Alerts/Recalls
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