Model Number U128 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received, a supplemental report will be filed at that time.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to safety mode and premature battery depletion.A new device was implanted and remains in service.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If additional information is received, a supplemental report will be filed at that time.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 due to system resets.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to safety mode and premature battery depletion.A new device was implanted and remains in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to safety mode and premature battery depletion.A new device was implanted and remains in service.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 due to system resets.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.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 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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