BOSTON SCIENTIFIC CORPORATION VITALIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number K283 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker reverted to safety mode resulting in the device switching to vvi 30.In safety mode the device will pace and sense in the ventricle at 30 paces per minute, which was different than previously programmed.Device replacement was planned for a future date.No adverse patient effects were reported.If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that this pacemaker reverted to safety mode resulting in the device switching to vvi 30.In safety mode the device will pace and sense in the ventricle at 30 paces per minute, which was different than previously programmed.Device replacement was planned for a future date.No adverse patient effects were reported.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is in hospital possession and will be returned by the hospital.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Search Alerts/Recalls
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