Model Number U128 |
Device Problem
High impedance (1291)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Date 08/25/2019 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements on the right ventricular (rv) and left ventricular (lv) leads.The rv and lv leads are not boston scientific products.The rv pace impedances were noted to be generally in the 500 ohm to 600 ohm range with excursions in the 900 ohm to 1484 ohm range over the past year.The lv pace impedances were noted to show a similar baseline in the 550 ohm to 620 ohm range with excursions in the 1000 ohm to 1500 ohm range over the past year.It was noted that the rate response trend (rrt) sensor was off and there were no stored episodes of noise.Boston scientific technical services (ts) discussed with the boston scientific representative (rep) that this could be related to a device header spring contact issue but the usual recommended troubleshooting should be performed, including performing isometric testing and checking serial impedances measurements.The rep indicated that they understood.The products remain in-service.No patient symptoms or adverse patient effects were reported.
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Event Description
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This supplemental report is being filed based on trend inclusion and an updated evaluation conclusion code.
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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 devices 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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