Model Number 3166 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 3 of 6.Reference mfr report: 1627487-2018-05265, 1627487-2018-05266, 1627487-2018-05268, 1627487-2018-05269 & 1627487-2018-05270.It was reported the patient's scs system would shut-off.Troubleshooting and reprogramming was unable to resolve the issue.The company representative suspected a possible break in the patient's scs extensions.Surgical intervention may be taken to address the issue.
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Event Description
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Device 3 of 6 : reference mfr report: 1627487-2018-05265, 1627487-2018-05266, 1627487-2018-05268, 1627487-2018-05269 & 1627487-2018-05270.Follow up information received identified the patient had his entire scs system removed.
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Search Alerts/Recalls
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