Model Number L311 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Malaise (2359)
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Event Date 08/02/2022 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker was interrogated.Upon interrogation, the pacemaker was found to be in safety mode.Additionally, it was indicated that the patient was not feeling well.Pacemaker replacement was recommended.No adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was added to the following fields to capture the explant of the device.Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this pacemaker was interrogated.Upon interrogation, the pacemaker was found to be in safety mode.Additionally, it was indicated that the patient was not feeling well.A pacemaker replacement was recommended.Subsequently, a revision procedure was performed and the 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.Interrogation of the device 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.Additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this pacemaker was interrogated.Upon interrogation, the pacemaker was found to be in safety mode.Additionally, it was indicated that the patient was not feeling well.A pacemaker replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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