Model Number 95001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abdominal Pain (1685)
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Event Date 10/03/2018 |
Event Type
malfunction
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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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It was reported the patient was implanted on (b)(6) 2018.It was stated they were experiencing lower stomach discomfort.
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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 received reported the patient had endometriosis and a full hysterectomy about 32 years ago.It was stated that their stomach bothered them after eating and when sitting/getting up from a seating position.The patient saw their general surgeon who placed the distal part of the shunt on (b)(6) 2019 for consultation.
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Search Alerts/Recalls
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