BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L331 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker was unable to be interrogated.Upon review, the device was found to be in safety mode.Subsequently, this pacemaker was successfully explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that this pacemaker was unable to be interrogated.Upon review, the device was found to be in safety mode.Subsequently, this pacemaker was successfully explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
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Search Alerts/Recalls
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