BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number L311 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
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Patient Problems
Fall (1848); Head Injury (1879); Hematoma (1884); Loss of consciousness (2418); Syncope/Fainting (4411); Asystole (4442)
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Event Date 09/13/2023 |
Event Type
Injury
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Event Description
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It was reported that this patient implanted with this pacemaker system was seen by neurosurgery for emergency treatment due to epidural hematoma after a patient fall and loss of consciousness.A device check revealed that the pacemaker was in safety mode, and external telemetry showed prolonged heart rate intervals with no visible pacing spikes.Additionally, it was suspected that the battery of this pacemaker had depleted prematurely as a longevity calculation from three months prior showed approximately 9 months remaining.This pacemaker was explanted, replaced, and shipped for return analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction to h10: updated to include analysis findings.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 had undergone resets.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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Event Description
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It was reported that this patient implanted with this pacemaker system was seen by neurosurgery for emergency treatment due to epidural hematoma after a patient fall and loss of consciousness.A device check revealed that the pacemaker was in safety mode, and external telemetry showed prolonged heart rate intervals with no visible pacing spikes.Additionally, it was suspected that the battery of this pacemaker had depleted prematurely as a longevity calculation from three months prior showed approximately 9 months remaining.This pacemaker was explanted, replaced, and shipped for return analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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