Model Number 3788 |
Device Problem
No Device Output (1435)
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Patient Problems
Inadequate Pain Relief (2388); Weight Changes (2607)
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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.
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Event Description
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Device 1 of 2: reference mfr.Report #1627487-2015-06486.It was reported the patient lost a significant amount of weight and as a result, both her left and right positioned ipgs are loose in the pockets.An sjm representative met with the patient and confirmed communication was intermittent with the patient's right ipg and a low battery warning was displayed.However, the patient's left positioned ipg was unable to establish communication with external devices.Surgical intervention is planned for a later date as the next course of action to address the issue.It is unknown at this time which ipg is the right versus left positioned ipg.
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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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Event Description
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Device 1 of 2.Reference mfr.Report #1627487-2015-06486.Additional information received identified surgical intervention took place on (b)(6) 2015 at which time both of the patient's ipgs were explanted and replaced.Effective stimulation was reportedly restored postoperative, and the issues were resolved.
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Search Alerts/Recalls
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