Model Number L301 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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The local area field representative was contacted for additional information regarding product return status.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 would not interrogate due to entering safety mode.Additionally, a longevity estimate from one month ago had shown approximately 6 months remaining on the battery of this pacemaker.Subsequently, this pacemaker was explanted and replaced.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 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.The local area field representative was contacted for additional information regarding product return status.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 would not interrogate due to entering safety mode.Additionally, a longevity estimate from one month ago had shown approximately 6 months remaining on the battery of this pacemaker.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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