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); Hypersensitivity/Allergic reaction (1907); Seroma (2069); Implant Pain (4561)
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Event Date 08/08/2021 |
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: m365sc8336500, model: sc-8336-50, serial: (b)(4), batch: 7074608.
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Event Description
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It was reported that the patient was having sudden onset of extreme pain and hypersensitivity at the ipg site.The patient underwent a procedure wherein upon opening of the ipg pocket, it was discovered that there was a cloudy fluid surrounding the ipg, and the ipg was explanted.The midline incision was opened and the lead tails were cut just below the anchor site.The lead tails were then pulled back through the ipg pocket and removed.The paddle portion of the lead was left in the epidural space in hope that the system can be replaced after the suspected infection clears.The patient was placed on antibiotics, and the explanted ipg was discarded.
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Search Alerts/Recalls
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