Model Number U228 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that this implantable pacemaker high out of range pacing impedance measurements on the left ventricular channel.Due to this, a lead safety switch was triggered.Reprograming options and further evaluation of the patient was discussed.This lead remains in service.No further 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 complaint summary 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 implantable pacemaker high out of range pacing impedance measurements on the left ventricular channel.Due to this, a lead safety switch was triggered.Reprograming options and further evaluation of the patient was discussed.This lead remains in service.No further adverse patient effects were reported.
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Search Alerts/Recalls
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