Model Number 3186 |
Device Problem
Impedance Problem (2950)
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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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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 2; reference mfr report: 1627487-2018-08715.It was reported the patient was experiencing inadequate pain relief from the scs system.The patient stated the system had slowly been losing effectiveness, and stopped working approximately two months ago.A company representative met with the patient and diagnostics of the patient's scs system found the patient's right lead had all invalid impedances, and the left lead had multiple invalid contacts.The representative was unable to resolve the issue.Surgical intervention may be necessary to address the issue.
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Event Description
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Device 2 of 2.Reference mfr report: 1627487-2018-08715.Additional information revealed that patient had leads explanted and replaced and the ipg was electively explanted and replaced.Postoperatively, patient had effective therapy.
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Search Alerts/Recalls
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