Model Number 3788 |
Device Problems
No Device Output (1435); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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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.(b)(4).
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Event Description
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It was reported the sjm representative was unable to establish communication between the patient's ipg and any external devices.The patient stated she has not had stimulation since (b)(6) 2015.The patient may undergo surgical intervention as the next course of action.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2016, where her ipg was explanted and replaced.The patient reported effective stimulation coverage postoperative.Surgical intervention resolved the reported issue.
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Search Alerts/Recalls
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