BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1232 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Diarrhea (1811); Fever (1858); Confusion/ Disorientation (2553); Cough (4457)
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Event Date 08/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: m365sc8336700, model: sc-8336-70, serial: (b)(4), batch/lot: (b)(4).
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Event Description
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It was reported that the patient had an infection at unknown location.Symptoms of confusion, coughing, fever, and loose stools were noted.The patient was hospitalized and was placed on antibiotics.It was unknown if infection was device related.All device components were explanted and were discarded by the medical facility.The patient was doing well postoperatively.
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Search Alerts/Recalls
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