Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Paraplegia (2448)
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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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It was reported by the patient's doctor that during surgery to implant the scs system the patient had developed a hematoma in the epidural space and developed paraplegia.The next day the patient had surgery to evacuate the hematoma.A company representative had follow up and the patient was in rehabilitation.
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Event Description
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Follow up information indicated the patient had been discharged from the inpatient rehabilitation unit at the hospital with a follow up appointment scheduled with the doctor.
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Event Description
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Follow-up identified the patient has recovered and is receiving effective stimulation from the system.
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Search Alerts/Recalls
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