Model Number 3156 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 05/17/2017 |
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 3 of 4.Reference mfr report: 1627487-2018-05638, 1627487-2018-05639 & 1627487-2018-05641.It was reported the patient complained of a "shocking" sensation in her low back that started approximately a year ago.Consequently, the patient stated she stopped using the scs stimulation.Surgical intervention may be taken to address the issue.
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Event Description
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Device 3 of 5: reference mfr report: 1627487-2018-05638, 1627487-2018-05639, 1627487-2018-05641 & 1627487-2018-09445.Follow up information received identified surgical intervention was taken and the patient's scs ipg was replaced.Postoperatively, the patient's scs system was programmed with the new scs ipg and the patient reported the shocking sensation was not present with the new ipg.The patient's scs ipg was added to the report as device 5.
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Search Alerts/Recalls
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