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Model Number 3149 |
Device Problem
High impedance (1291)
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Patient Problems
Fall (1848); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 09/13/2017 |
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 2 of 4.Reference mfr.Report#: 1627487-2018-00933, reference mfr.Report#: 1627487-2018-00935, reference mfr.Report#: 1627487-2018-00936.The patient has an scs system for off-label use.It was reported the patient has been receiving inadequate therapy due to receiving stimulation in unintended areas after falling.An impedance check revealed high impedance on the patient's right occipital lead.As a result, the patient may undergo surgical intervention to address the issue.Note: all of the patient's leads are being reported because it is unknown which lead is liable.
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Event Description
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Device 2 of 4.Reference mfr.Report#: 1627487-2018-00933 , reference mfr.Report#: 1627487-2018-00935 , reference mfr.Report#: 1627487-2018-00936.Follow-up revealed the patient's leads were explanted and replaced.Surgical intervention resolved the patient's issue.
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Search Alerts/Recalls
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