Model Number L301 |
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 08/17/2023 |
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 was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis.
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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.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 telemtry data confirmed it was operating in safety mode 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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Search Alerts/Recalls
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