BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G141 |
Device Problem
High impedance (1291)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This device remains implanted, therefore technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported during a routine follow up appointment, that this cardiac resynchronization defibrillator device exhibited high, out of range pacing impedance (greater than 3,000 ohms).No pacing inhibition and no asystole was reported.No other out of range measurements were reported.Lead integrity testing was completed with device provocation and manipulation, the high, out of range pacing impedance could not be reproduced.The device remains implanted.No adverse patient effects were reported.
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Event Description
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It was reported during a routine follow up appointment, that this cardiac resynchronization defibrillator device exhibited high, out of range pacing impedance (greater than 3,000 ohms).No pacing inhibition and no asystole was reported.No other out of range measurements were reported.Lead integrity testing was completed with device provocation and manipulation, the high, out of range pacing impedance could not be reproduced.The device remains implanted.No adverse patient effects were reported.A technical service (t/s) consultant reviewed the available device data, noting that the high, out of range pacing impedance (greater than 3,000 ohms) episode occurred in (b)(6) 2020, and (b)(6) 2020, then went back to normal.Noting the episodes seem to be "one-offs" and not consistent.The out of range impedances go back to normal the next day.T/s recommended performing a 1.1 j shock to evaluate lead integrity.T/s recommended monitoring the patient closely through a home monitor.The device remains implanted.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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