Model Number 3788 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the patient did not recharge the ipg as recommended.In turn, the ipg became inoperable.Surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.The directions for use states that the implant must be charged every 30 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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Event Description
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Additional information received identified that patient underwent surgical intervention on (b)(6) 2020 wherein, the ipg was explanted and replaced.Effective therapy was restored post operatively.
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Search Alerts/Recalls
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