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 10/31/2023 |
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 an april 2023 device check of this pacemaker showed 11 months remaining on the battery and the device was nearing the elective replacement time (ert).A follow-up check 6 months later indicated that the pacemaker had entered safety mode and recorded an unspecified error code.Subsequently, 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.
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Event Description
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It was reported that an (b)(6) 2023 device check of this pacemaker showed 11 months remaining on the battery and the device was nearing the elective replacement time (ert).A follow-up check 6 months later indicated that the pacemaker had entered safety mode and recorded an unspecified error code.Subsequently, this pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.Additional information received reported that clarified that this pacemaker had entered safety mode and device interrogation revealed the following codes: 0x0, 0x0, 0x0.The explanted pacemaker was received for analysis.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 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 an (b)(6) 2023 device check of this pacemaker showed 11 months remaining on the battery and the device was nearing the elective replacement time (ert).A follow-up check 6 months later indicated that the pacemaker had entered safety mode and recorded an unspecified error code.Subsequently, this pacemaker was explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.Additional information received reported that clarified that this pacemaker had entered safety mode and device interrogation revealed the following codes: 0x0, 0x0, 0x0.The explanted pacemaker was received for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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