Model Number U125 |
Device Problem
High impedance (1291)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received a supplemental report will be submitted.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker and non boston scientific right ventricular lead exhibited pace impedance measurements greater than 2,000 ohms, resulting in a lead safety switch.Technical services discussed programming options.The device 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 and non boston scientific right ventricular lead exhibited pace impedance measurements greater than 2,000 ohms, resulting in a lead safety switch.Technical services discussed programming 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 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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