BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U125 |
Device Problems
High impedance (1291); Impedance Problem (2950)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/27/2020 |
Event Type
malfunction
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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 high out-of-range pace impedance measurements greater than 2,000 ohms.Also exhibited were variances or spikes in the non-boston scientific right atrial (ra) lead pace impedance measurements, ranging from 400 ohms to the 1,500 ohms range.Technical services (ts) discussed spring contact issues with non-bsc leads and troubleshooting options.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's 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 high out-of-range pace impedance measurements greater than 2,000 ohms.Also exhibited were variances or spikes in the non-boston scientific right atrial (ra) lead pace impedance measurements, ranging from 400 ohms to the 1,500 ohms range.Technical services (ts) discussed spring contact issues with non-bsc leads and troubleshooting options.The device remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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