Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Numbness (2415); Fluid Discharge (2686)
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Event Date 06/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) via a manufacturer¿s representative (rep).The rep reported that the patient was having post-operative complications on (b)(6) 2018.The rep reported that the patient was having lower extremity numbness and abdominal clots.The rep reported that the device was explanted.The issue was resolved.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a manufacturer¿s representative (rep).The rep reported that the cause of the numbness and abdominal clots was an epidural hematoma.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the hcp.It was reported that the cause was completed revision surgery complicated by bleeding/oozing.Actions interventions taken to resolve the issue were surgical re-exploration and evacuation.The epidural hematoma was resolved but remains neurologically compromised.No further complications were reported/anticipated.
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Search Alerts/Recalls
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