Model Number 3383 |
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 2 of 2.Reference mfr.Report:1627487-2015-03513.
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Event Description
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Device 2 of 3.Reference mfr.Report:1627487-2015-03513 & 1627487-2016-01198.
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Event Description
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Device 2 of 5.Reference mfr.Report:1627487-2015-03513, 1627487-2016-01198, 1627487-2016-01306, & 1627487-2016-01307.Additional information received identified the scs extensions (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 2 of 5.Reference mfr.Report: 1627487-2015-03513, 1627487-2016-01198, 1627487-2016-01306, and 1627487-2016-01307.
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Search Alerts/Recalls
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