Model Number U125 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2022 |
Event Type
Injury
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Event Description
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It was reported that this implantable pacemaker was explanted due to entering in safety mode.Another device was implanted instead.No further adverse patient effects were reported.
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Event Description
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It was reported that this implantable pacemaker was explanted due to entering in safety mode.Another device was implanted instead.This device was returned to boston scientific for analysis.No further adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was corrected from the following fields: h6: impact codes.
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Event Description
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It was reported that this implantable pacemaker was explanted due to entering in safety mode.Another device was implanted instead.This device was returned to boston scientific for analysis.No further adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was interrogated with a programmer and found to be operating in safety mode.This device was not able to maintain telemetry connection long enough to obtain a memory download for review.Testing of the interior of the device indicated that the element composition did not have hydrogen counts present.The device case was removed to facilitate inspection and testing of the internal components.The battery was disconnected from the hybrid assembly and detailed testing determined that this device experienced high impedance in the battery.However, a definitive cause of this high impedance behavior has not been determined.Additional information was corrected from the following fields: h6: impact codes.
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Search Alerts/Recalls
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