Model Number M0067001210 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pneumonia (2011)
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Event Date 11/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2019.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf impact code f2303 captures the reportable event of medication required.
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Event Description
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It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced pneumonia.The patient was given antibiotics for c.Difficile and pneumonia.
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Event Description
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It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced pneumonia.The patient was given antibiotics for c.Difficile and pneumonia.Additional information received on (b)(6) 2023: it was reported that in addition to pneumonia, the patient experienced pseudomembranous colitis and was given antibiotics for c.Difficile infection.
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Manufacturer Narrative
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Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in november 2019.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) and block h6 (patient codes) have been updated based on the additional information received on march 20, 2023.Block h6: imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf patient code e2326 captures the reportable event of pseudomembranous colitis.Imdrf impact code f2303 captures the reportable event of medication required.
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Search Alerts/Recalls
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