Model Number L101 |
Device Problems
Premature Discharge of Battery (1057); 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 01/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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The local area field representative was contacted for additional information.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 pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The local area field representative was contacted for additional information.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 pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.Additional information received reported that, prior to explant, this pacemaker had recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- 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, determined it had undergone resets, and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.
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Event Description
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It was reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.Additional information received reported that, prior to explant, this pacemaker had recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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