Model Number U128 |
Device Problem
High impedance (1291)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is being requested from the field.If additional information is received this report will be updated.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific right ventricular (rv) lead exhibited jumpy pace impedance measurements of greater than 2,000 ohms, triggering a lead safety switch (lss).Technical services (ts) discussed troubleshooting options.The health care professional (hcp) was going to switch the patients next remote follow up to an in-office check to further evaluate.The device 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 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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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific right ventricular (rv) lead exhibited jumpy pace impedance measurements of greater than 2,000 ohms, triggering a lead safety switch (lss).Technical services (ts) discussed troubleshooting options.The health care professional (hcp) was going to switch the patients next remote follow up to an in-office check to further evaluate.The device remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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