Model Number 3788 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 05/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient experienced heating when charging their ipg.Hence the patient stopped charging the ipg and turned off the stimulation.Surgical intervention may be undertaken to address the issue.
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Event Description
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Additional information received identified that patient tripped over the cord and reportedly broke her hip.Patient went to the er to rule out hip fracture.As such, surgical intervention is pending.
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Manufacturer Narrative
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Patient weight.Device manufacture date: the device information has been corrected to reflect new information.
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Event Description
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Additional information was received that the ipg became inoperable due to lack of recharging as recommended.Surgery occurred during which the ipg was explanted and replaced.Post-operatively, therapy was restored.
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Manufacturer Narrative
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The directions for use states that the implant must be charged every 30 to 90 days to avoid battery depletion. based on the information received, the cause of the reported incident is related to user error.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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