Model Number 3788 |
Device Problems
Failure to Charge (1085); Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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It was reported the patient has not used or charged her scs system in over a year.It was also reported the patient's ipg is not functional and the patient is without stimulation.The patient is unable to locate her external devices.The patient may undergo surgical intervention as the next course of action.The event date is unknown.
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Event Description
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Follow-up information revealed the surgeon decided to try non-surgical interventions to treat the patient's pain at this time.
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Manufacturer Narrative
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Corrections/removal reporting number: 1627487-12192011-003-r.This ipg serial number was included in field advisories.(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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Manufacturer Narrative
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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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Search Alerts/Recalls
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