Model Number U128 |
Device Problem
High impedance (1291)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) detected high out-of-range right ventricular (rv) lead pacing impedances.There was no evidence of noise.Technical services (ts) noted they could not rule out an rv lead fracture or possible spring contact issue at this point.The device was reprogrammed to bipolar pace and unipolar sense.The patient will be seen again in a month.No adverse patient effects were reported.The device remains implanted and in service.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) detected high out-of-range right ventricular (rv) lead pacing impedances.There was no evidence of noise.Technical services (ts) noted they could not rule out an rv lead fracture or possible spring contact issue at this point.The device was reprogrammed to bipolar pace and unipolar sense.The patient will be seen again in a month.No adverse patient effects were reported.The device remains implanted and in service.
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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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Search Alerts/Recalls
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