Model Number L211 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problems
Fainting (1847); Dizziness (2194); Syncope/Fainting (4411)
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Event Date 07/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Event Description
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It was reported that the patient implanted with this pacemaker was admitted to the coronary intensive care unit (icu) after reporting episodes of dizziness with fainting.The pacemaker was interrogated and a warning message was displayed on the programmer, indicating the device was operating in safety mode.The device settings were permanently limited to vvi mode pacing at 72 bpm, with an output of 5v.Technical services discussed the device would need to be explanted and replaced.The local field representative reported the device was explanted two days later.No additional adverse patient effects were reported.
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Event Description
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It was reported that the patient implanted with this pacemaker was admitted to the coronary intensive care unit (icu) after reporting episodes of dizziness with fainting.The pacemaker was interrogated and a warning message was displayed on the programmer, indicating the device was operating in safety mode.The device settings were permanently limited to vvi mode pacing at 72 bpm, with an output of 5v.Technical services discussed the device would need to be explanted and replaced.The local field representative reported the device was explanted two days later.No additional adverse patient effects were reported.
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Manufacturer Narrative
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At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Interrogation of the device confirmed it was operating in safety mode and that brady therapy remained available.Review of device memory identified three faults recorded on (b)(6) 2019.The faults resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory, but the faults recurred, and the device reverted to safety mode again.The device case was opened and testing of the internal components found no anomalies.Detailed analysis revealed the memory faults were caused by a defective digital integrated circuit chip.
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Search Alerts/Recalls
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