Model Number LNQ11 |
Device Problems
Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
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Patient Problems
Syncope (1610); Death (1802); Pain (1994); Seizures (2063); Skull Fracture (2077); Injury (2348)
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Event Date 07/17/2016 |
Event Type
Death
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Manufacturer Narrative
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Non-healthcare professional this device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) patient sustained "serious, painful and permanent injuries" which caused the patient "to endure great pain and suffering" due to the icm being "negligently, carelessly, and recklessly designed, manufactured, imported, distributed and sold".It was further reported that the device "deviated from the design specifications, failed to properly affix warnings or instructions and (was) defectively designed and manufactured".The device is no longer in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) patient's physician did not receive data showing a four second variance in patient's heartbeat until four days after the data was recorded.It was alleged by an attorney that during the four day time frame the patient experienced a second variance in their heartbeat which caused the icm patient to lose consciousness, fall and suffer serious bodily injuries including a fractured skull which allegedly caused a massive seizure which led to the patient's death.
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Search Alerts/Recalls
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