BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Itching Sensation (1943); Nausea (1970); Rash (2033); Vomiting (2144); Inadequate Pain Relief (2388); Swelling/ Edema (4577)
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Event Date 01/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: 7072552/7072554.
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Event Description
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It was reported that the patient was experiencing inadequate stimulation.It was also reported that the patient has had multiple medical complaints including itching, rashes, swelling, vomiting, nausea, and had one episode of chest pain.The patient was prescribed with medrol dosepak medication.
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Search Alerts/Recalls
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