Model Number L331 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); 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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Manufacturer Narrative
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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 had entered safety mode soon after the patient had participated in bumper cars with the magnetic poles that connected with the ceiling.In addition, the battery of this pacemaker was suspected to have depleted prematurely, as a longevity estimate from (b)(6) 2022 had showed 7-8 years remaining on this battery.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis.
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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 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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Event Description
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It was reported that this pacemaker had entered safety mode soon after the patient had participated in bumper cars with the magnetic poles that connected with the ceiling.In addition, the battery of this pacemaker was suspected to have depleted prematurely, as a longevity estimate from december 2022 had showed 7-8 years remaining on this battery.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis.
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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 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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Event Description
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It was reported that this pacemaker had entered safety mode soon after the patient had participated in bumper cars with the magnetic poles that connected with the ceiling.In addition, the battery of this pacemaker was suspected to have depleted prematurely, as a longevity estimate from (b)(6) 2022 had showed 7-8 years remaining on this battery.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis.
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Search Alerts/Recalls
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