BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-2218-50E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Respiratory Distress (2045); Complaint, Ill-Defined (2331)
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Event Date 07/20/2020 |
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-linear leads, upn: m365sc221850e0, model: sc-2218-50e, serial: (b)(4), batch: (b)(4).
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Event Description
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It was reported that during a trial procedure, the patient experienced respiratory failure on the table which was not device related.It was reported that this was due to patients sleep apnea and enlarged abdominal area.The leads were discarded.
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Search Alerts/Recalls
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