Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 06/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
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Event Description
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It was reported the patient complained of not receiving effective stimulation therapy coverage from the scs system.A company representative met with the patient and attempted to reprogram the patient's scs system, but the patient reported only getting unintended rib stimulation.An x-ray was taken and confirmed the scs lead had migrated.Surgical intervention may be taken to address the issue.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for evaluation.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Follow up information received identified the patient's scs lead was revised and moved to the t9 space.Postoperative, all painful areas were covered with adequate pain relief.
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Search Alerts/Recalls
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