Model Number 3788 |
Device Problems
Nonstandard Device (1420); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/25/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient has not charged the ipg for a month.The ipg is no longer communicating with the charger and the programmer displays a communication error code.A replacement charger did not resolve the issue.Surgical intervention may be taken to address the issue.
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Manufacturer Narrative
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Additional information was received such as date of explant.During processing of this complaint, attempts were made to obtain weight but not received.
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Event Description
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Additional information received indicated the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.Therapy was restored postoperatively.
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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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Search Alerts/Recalls
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