Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 04/13/2018 |
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 that the patient experienced a significant blood loss following a permanent paddle lead implant on (b)(6) 2018 and as a result was transferred from the surgery center to the hospital.Reportedly, the lead was difficult to implant but the reason for the blood loss is still unknown.The patient was discharged from the hospital.
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Event Description
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Additional follow-up revealed the patient was hospitalized for 3 days for the issue.However, current patient status is unknown.In addition, no known intervention was undertaken to resolve the issue.
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Search Alerts/Recalls
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