Model Number 3186 |
Device Problem
High impedance (1291)
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Patient Problems
Headache (1880); Inadequate Pain Relief (2388)
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Event Type
Injury
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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 2 of 2: reference mfr report: 1627487-2017-03623.It was reported that the patient was experiencing ineffective therapy due to high impedances.In addition, the patient reports that they were experiencing headaches while the therapy was on.As a result, surgical intervention may be pending to address this issue.
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Event Description
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Device 2 of 2: reference mfr report: 1627487-2017-03623.Follow up revealed that the patient underwent surgical intervention on (b)(6) 2017 to have one of their leads replaced.During the procedure, it was noted the physician electively explanted and replaced the patient's ipg with a different model as well.Issue has been resolved.Note: it is unknown which lead was explanted.
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Event Description
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Device 2 of 2; reference mfr report: 1627487-2017-03623.Follow up revealed that the lead that was explanted was serial number (b)(4).
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Search Alerts/Recalls
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