Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 # 3006705815-2017-07389, 3006705815-2017-07390, 1627487-2017-08693.It was reported that the patient was hospitalized on (b)(6) 2017 due to an infection at lead site and double pneumonia.Patient is currently receiving iv antibiotics as a result, entire scs system was explanted on (b)(6) 2017.
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Event Description
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Device 3 of 4, reference mfr report # 3006705815-2017-07389, 3006705815-2017-07390, 1627487-2017-08693.Follow up information revealed patient was released from the hospital 2 days postoperative.Patient¿s infection has resolved after scs explant.
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Search Alerts/Recalls
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