Model Number L311 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)
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Patient Problems
Weakness (2145); Dizziness (2194); No Code Available (3191)
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Event Date 12/03/2019 |
Event Type
Injury
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Event Description
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It was reported that this patient presented to the emergency room with weakness, dizziness, and lightheadedness.A device check revealed that the device was operating in safety mode.The patient denied having any recent procedures or radiation exposure.It was concluded that ventricular oversensing was occurring, post safety mode switch.The pacemaker was removed and replaced.No additional adverse patient effects were reported.This product has been returned.This report will be updated upon analysis completion.
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Manufacturer Narrative
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The patient code 3191 accounts for the surgical intervention that occurred.Upon receipt at our post market quality assurance laboratory, the clinically observed error message was reproduced.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message.Following the reset, the device reverted to a safety mode with limited programmability, in which single chamber pacing and defibrillation therapy were available.
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Event Description
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It was reported that this patient presented to the emergency room with weakness, dizziness, and lightheadedness.A device check revealed that the device was operating in safety mode.The patient denied having any recent procedures or radiation exposure.It was concluded that ventricular oversensing was occurring, post safety mode switch.The pacemaker was removed and replaced.No additional adverse patient effects were reported.This product has been returned and a device evaluation was completed.
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Search Alerts/Recalls
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