Model Number L311 |
Device Problems
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 09/29/2023 |
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 entered safety mode.Upon device interrogation, the following codes were revealed: 0x0 0x0 0x0.Additional information received indicated that 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.Device telemetry data confirmed it was operating in safety mode and determined it had undergone resets.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 entered safety mode.Upon device interrogation, the following codes were revealed: 0x0 0x0 0x0.Additional information received indicated that 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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