Model Number 3788 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2021 |
Event Type
Injury
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Event Description
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It was reported the patient's ipg no longer accepts a charge, the patient still has therapy.Surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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The reported even for inoperable ipg was not confirmed.At receipt, the ipg successfully communicate with lab utilities.The return ipg accepted charge and was fully recharge at lab charging bank.It also passed all functional testing (bench and autotest).No root cause was identified for the reported issue.
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Event Description
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It was reported surgical intervention was undertaken wherein the ipg was explanted and replaced.Surgical intervention addressed the issue.
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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 event could not be conclusively determined.
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Search Alerts/Recalls
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