Model Number U125 |
Device Problem
High impedance (1291)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/27/2021 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range (oor) pacing impedances measuring greater than 2000 ohms on the non-boston scientific right ventricular (rv) lead.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was also noted there was a gradual increase in impedances over the last year.This crt-p and non- boston scientific rv lead remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out-of-range (oor) pacing impedances measuring greater than 2000 ohms on the non-boston scientific right ventricular (rv) lead.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.It was also noted there was a gradual increase in impedances over the last year.This crt-p and non- boston scientific rv lead remains in service.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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Search Alerts/Recalls
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