BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U125 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2021 |
Event Type
malfunction
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific (bsc) right atrial (ra) lead exhibited pace impedance measurements of greater than 3,000 ohms, resulting in a lead safety switch.Myopotential noise and signal artifact monitoring (sam) episodes were observed due to minute ventilation (mv) oversensing, resulting in the mv sensor being disabled.Technical services (ts) recommended in clinic testing of the non bsc ra lead as it was probable that the lead was fractured.The device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If additional information is received, a supplemental report will be filed at that time.
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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 (bsc) right atrial (ra) lead exhibited pace impedance measurements of greater than 3,000 ohms, resulting in a lead safety switch.Myopotential noise and signal artifact monitoring (sam) episodes were observed due to minute ventilation (mv) oversensing, resulting in the mv sensor being disabled.Technical services (ts) recommended in clinic testing of the non bsc ra lead as it was probable that the lead was fractured.The device remains in service.No adverse patient effects were reported.
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