Model Number 3716 |
Device Problems
Corroded (1131); High impedance (1291)
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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.
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Event Description
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Device 1 of 2.Reference mfr.Report:1627487-2015-03514.It was reported the patient (b)(6) is no longer receiving stimulation.Diagnostics revealed high impedance values.X-rays revealed no anomalies.As a result, the patient underwent exploratory surgery in (b)(6) of 2015 (exact date is unknown at this time) during which corrosion in the scs ipg header and on the scs extension contacts was found.Surgical intervention regarding the scs ipg and scs extension will be taken at a later date to address the 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:1627487-2015-03514 & 1627487-2016-01198.Additional information received identified the patient underwent surgical intervention on (b)(6) 2016 during which the scs ipg and scs extensions (it was determined the patient had 2 extensions) were explanted and replaced.The other scs extension (lot, manufacture and expiration dates are unknown) is being reported as device 3.
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Event Description
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Device 1 of 5.Reference mfr.Report:1627487-2015-03514, 1627487-2016-01198, 1627487-2016-01306, & 1627487-2016-01307.Additional information received identified the scs leads (device 2 &3) are from the same lot.It was also reported the issue was resolved with the explant and replacement of the ipg and extensions.As a result, surgical intervention regarding the scs leads will be taken at a later date to address the issue.The scs leads (both devices have (b)(4) serial numbers) are being reported as device 4 and device 5 respectively.
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Event Description
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Device 1 of 5: reference mfr.Report:1627487-2015-03514, 1627487-2016-01198, 1627487-2016-01306, & 1627487-2016-01307.
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Search Alerts/Recalls
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