Model Number U125 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/19/2020 |
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 noise, oversensing, pacing inhibition and high pace impedance measurements remaining within normal range.There was intermittent minute ventilation (mv) sensor noise that was not being oversensed.The patient was pacemaker dependent at the time.Ts noted there may have been asystole of greater than two seconds.Ts discussed troubleshooting options and recommended programming mv off.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 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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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 noise, oversensing, pacing inhibition and high pace impedance measurements remaining within normal range.There was intermittent minute ventilation (mv) sensor noise that was not being oversensed.The patient was pacemaker dependent at the time.Ts noted there may have been asystole of greater than two seconds.Ts discussed troubleshooting options and recommended programming mv off.The device remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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