BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1160 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fever (1858); Pain (1994); Swelling (2091); No Code Available (3191)
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Event Date 04/20/2020 |
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-2218-70, serial: (b)(4), batch: 7070076/5170176/7056466/7070142.
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Event Description
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It was reported that the patient had an infection at the ipg and lead site.Symptoms of infection were swelling, pain and fever.The physician believed that the infection was not device related however, the infection had spread from the last revision procedure (mfr report number 3006630150-2020-02028).The patient was placed on antibiotics.No device malfunction was suspected.All device components were explanted and were discarded.
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Search Alerts/Recalls
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