Model Number L311 |
Device Problems
Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this pacemaker had entered safety mode.As a result, the patient was symptomatic due to oversensing of unipolar pacing.This pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.
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Event Description
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It was reported that this pacemaker had entered safety mode.As a result, the patient was symptomatic due to oversensing of unipolar pacing.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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The product has been received for analysis.This report will be updated upon completion of analysis.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 that critical 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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