Model Number 3788 |
Device Problems
Device Stops Intermittently (1599); Impedance Problem (2950)
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Patient Problems
Device Overstimulation of Tissue (1991); 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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Device #1 of 2: reference mfr.Report: 1627487-2016-03748, the lead information is unknown.It was reported ((b)(6)) the patient is experiencing a sudden loss of power occurring 1-5 times a day.When the power loss occurs the patient experiences overstimulation in his back at the anchor site.Lead diagnostics revealed multiple invalid impedances.Surgical intervention may be pending to address this issue.
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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 3: reference mfr.Report: 1627487-2016-0348 and 1627487-2016-04826.
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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 3: reference mfr.Report: 1627487-2016-03448 and 1627487-2016-04826.0 follow up information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace the extension which resolved the issue.Therapy has been restored.
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Search Alerts/Recalls
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