BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L321 |
Device Problems
Off-Label Use (1494); 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 12/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this patient underwent a magnetic resonance imaging (mri) during which this pacemaker displayed safety mode.It was noted that this pacemaker system was non mri conditional.This patient was pacemaker dependent at that time.This pacemaker was explanted and replaced with a different device, which remains in service.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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