Model Number L321 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
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Patient Problems
Bradycardia (1751); Device Overstimulation of Tissue (1991)
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Event Date 02/24/2024 |
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 the patient implanted with this pacemaker system experienced muscle stimulation and pacing pauses less than two seconds.It was determined that this pacemaker had entered safety mode.This pacemaker was explanted, replaced, and returned for analysis.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.Device telemetry data 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 the patient implanted with this pacemaker system experienced muscle stimulation and pacing pauses less than two seconds.It was determined that this pacemaker had entered safety mode.This pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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